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18,222 catalysts · 4,728 grant · 3,380 8k filing · 2,620 approval · 2,108 device 510k · 1,692 device recall · 1,464 device pma
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18,222 catalysts · 4,728 grant · 3,380 8k filing · 2,620 approval · 2,108 device 510k · 1,692 device recall · 1,464 device pma
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. — Reason: Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). — Status: Ongoing
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Special
Product code: CCK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Special
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Abbreviated
Product code: LYZ. Advisory committee: General Hospital. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Special
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: QOG. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOM. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
Biograph mMR. Model Number: 10433372. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Verio. Model Number: 10276755. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Lumina (DE). Model Number: 11344916. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352; — Reason: a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. — Status: Ongoing
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Vida Fit. Model Number: 11410481. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Skyra fit. Model Number: 10849580. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
MAGNETOM Cima.X (DE). Model Number: 11647158. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System — Reason: A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS). — Status: Ongoing
MAGNETOM Verio Dot Upgrade. Model Number: 10684334. — Reason: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. — Status: Ongoing