calendar
215 catalysts · 3,045 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 578 earnings
next 91 dayslessmore
MonWedFri
215 catalysts · 3,045 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 578 earnings
no tagged catalysts yet
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids. — Reason: Potential for rubber fragment detachment during use. — Status: Ongoing
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. — Reason: Potential for rubber fragment detachment during use. — Status: Ongoing
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation — Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. — Status: Ongoing
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation — Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. — Status: Ongoing
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment — Status: Ongoing
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851 — Reason: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. — Status: Ongoing
DxC 700 AU, REF: B86444, B86446 — Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment. — Status: Ongoing
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 — Reason: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). — Status: Ongoing
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). — Reason: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. — Status: Ongoing
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS). — Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. — Status: Ongoing
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013 — Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. — Status: Ongoing
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 — Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. — Status: Ongoing
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 — Reason: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. — Status: Ongoing
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. — Status: Ongoing
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X — Reason: Impactor handle may be missing cross-pin — Status: Ongoing
IBA Proton Therapy System - PROTEUS 235 — Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used. — Status: Ongoing
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No — Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. — Status: Ongoing
Campy CVA Medium 100/PK, R01272 — Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
Artelon FlexBand Dynamic Matrix Ref: 31057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12 — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
BD Kiestra" ReadA; Catalog No.: 446948. — Reason: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity. — Status: Ongoing
Battery Charging Station; Model: 0998-00-0802; — Reason: The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR — Reason: Software anomaly in the patient positioning system may result in positional discrepancy. — Status: Ongoing
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Artelon FlexBand Plus Ref: 41054 & 41057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR — Reason: Software anomaly in the patient positioning system may result in positional discrepancy. — Status: Ongoing
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable — Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. — Status: Ongoing
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Artegraft Vascular Graft; REF#: AG740; — Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. — Status: Ongoing
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; — Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. — Status: Ongoing
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2" — Reason: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. — Status: Ongoing
Burlington Medical, Wrap Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Leg Wraps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Vest — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Burlington Medical, Demi Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit — Reason: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units — Status: Ongoing
Burlington Medical, Kilt Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing