166 results
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Sources: EU EUDAMED, US FDA
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GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
FDA Recall
Terminated
·Natus Medical Inc·Product code ETY·June 27, 2005
A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.
FDA Recall
Terminated
·A-Dec Inc·Product code KLC·April 1, 2009
IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEC·November 11, 2010
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·January 16, 2020
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Recall
Terminated
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·March 2, 2018
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·December 11, 2020
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
FDA Recall
Terminated
·Getinge/Castle, Inc.·Product code MEC·March 25, 2003
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CEC·November 8, 2013
Dimension Free Thyroxine (FT4L) Flex reagent cartridge
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·February 10, 2020
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Recall
Terminated
·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018
Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003
Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·June 30, 2014
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CEC·March 5, 2018
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·May 20, 2019
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
FDA Recall
Open, Classified
·Steris Corporation·Product code MEC·April 10, 2023