20 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
FDA Recall
Open, Classified
·Steris Corporation·Product code MEC·April 10, 2023
Washer Disinfector Aquadis 56; Model Number: 56A
FDA Recall
Open, Classified
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·April 2, 2025
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
FDA Recall
Open, Classified
·Steris Corporation·Product code MEC·November 19, 2025
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code MEC·April 1, 2022
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
FDA Recall
Open, Classified
·Steris Corporation·Product code MEC·November 19, 2025
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
FDA Recall
Open, Classified
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·August 29, 2025
Washer Disinfector Aquadis 56; Model Number: 56M
FDA Recall
Open, Classified
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·April 2, 2025
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code MEC·April 13, 2022
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code MEC·April 13, 2022
OEC Elite Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC 9900 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
OEC 9800 Systems with 9-inch Image Intensifier
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Recall
Open, Classified
·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023