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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 — Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. — Status: Ongoing
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S — Reason: Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted. — Status: Ongoing
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light — Reason: Due to battery component overheating while charging resulting in melting of internal components and causing smoke. — Status: Ongoing
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer — Reason: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. — Status: Ongoing
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only — Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. — Status: Ongoing
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; — Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. — Status: Ongoing
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. — Reason: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users. — Status: Ongoing
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers. — Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. — Status: Ongoing
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. — Reason: Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. — Status: Ongoing
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system. — Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. — Status: Ongoing
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. — Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide — Reason: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; — Reason: The possibility for this product that is intended for demonstration purposes only to be placed in patients. — Status: Ongoing
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length — Reason: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit. — Status: Ongoing
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. — Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; — Reason: A potential issue with the seal integrity of header bag packaging. — Status: Ongoing
IntelePACS - InteleConnect / TechPortal — Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making. — Status: Ongoing
MONARCH Bronchoscope. Model Number: MBR-000211-B — Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. — Status: Ongoing
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 — Reason: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. — Status: Ongoing
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing
CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Cardiosave Rescue — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing
Cardiosave Hybrid — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; — Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used. — Status: Ongoing
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
MAMMOMAT Inspiration; — Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. — Status: Ongoing