Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 474 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 11, 2018	B105/125 Patient Monitor. The device is a portable multiparameter unit to ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Sep 11, 2018	PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE ...	Patient monitors may restart due to network overload caused by network configuration.	Class II	GE Healthcare, LLC
Aug 31, 2018	Solar 8000i Patient Monitoring System is used to monitor physiologic paramet...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 4000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 3000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Solar 8000M Patient Monitoring System is used to monitor physiologic paramet...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Solar 9500 Information Monitoring System is used to monitor physiologic para...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 31, 2018	Dash 5000 Patient Monitoring System is used to monitor physiologic parameter ...	The patient monitors may simultaneously restart as designed if all are connected to the same netw...	Class II	GE Healthcare, LLC
Aug 30, 2018	Centricity Universal Viewer with Cross Enterprise Display This impacts produc...	Remote comparison studies displayed may be associated with the wrong patient, without a caution i...	Class II	GE Healthcare, LLC
Jul 12, 2018	Revolution CT systems with the SmartStep Option The system is intended for...	On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on imag...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery NM/CT 670 ES, model 5376204-70-57	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	CT Goldseal BrightSpeed 16 PWR TIO 2 YR	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery RT labeled as: a. MID BJG; b. HVY BJG	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4...	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery NM/CT 670 Pro, model 5376204-70-54	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	Revolution CT 160 1.5D STD WAUK	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Optima CT 540	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Optima CT 520	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, l...	When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remot...	Class II	GE Healthcare, LLC
May 24, 2018	Discovery MI Digital Ready	DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be ...	Class II	GE Healthcare, LLC
May 24, 2018	Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ...	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
May 24, 2018	CT Goldseal Optima CT 600	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p...	Class II	GE Healthcare, LLC
Dec 15, 2017	Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Pro...	if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected...	Class II	GE Healthcare, LLC
Dec 15, 2017	Uterine Electromyographic Monitor -Monica IF24 Interface System Product Us...	if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected ...	Class II	GE Healthcare, LLC
Oct 30, 2017	VariCam	A potential hazardous situation may occur if the collimator locking handle is not properly placed...	Class II	GE Healthcare, LLC
Oct 30, 2017	Discover VH/Millennium VG Nuclear Medicine Imaging System	A potential hazardous situation may occur if the collimator locking handle is not properly placed...	Class II	GE Healthcare, LLC
Oct 4, 2017	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered deliv...	Non-Conforming devices were shipped from the service center without proper evaluation and therefo...	Class II	GE Healthcare, LLC
Oct 4, 2017	DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used...	Non-Conforming devices were shipped from the service center without proper evaluation and therefo...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX ...	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Revolution EVO X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT660, CT680 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 670 CZT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery Ml X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Lightspeed RT16 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare LightSpeed VCT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery IQ X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT540 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery Ml DR X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 570c X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare BrightSpeed X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare lnnova IGS 540 ACT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT520 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 5, 2017	Infant Warmer System (IWS)	GE Healthcare has recently become aware of a potential safety issue related to loose screws in t...	Class II	GE Healthcare, LLC
May 2, 2017	Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1	Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction	Class II	GE Healthcare, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.