Recall archive
153 recalls · page 3 of 7
Reported Dec 25, 2019
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2019
Giraffe OmniBed infant warmer
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2019
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
FDA (openFDA device enforcement)
Reported Nov 6, 2019
CardioLab/ComboLab Recording Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation…
FDA (openFDA device enforcement)
Reported Oct 30, 2019
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS…
FDA (openFDA device enforcement)
Reported Oct 16, 2019
AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details — The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2019
Proteus XR/a (SlOK : K993090)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
FDA (openFDA device enforcement)
Reported Aug 7, 2019
GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2019
MAC VU360, Model Number 2030360-001, Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s…
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Additional low dose radiation exposure.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2019
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2019
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details — There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2019
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.GE Healthcare, LLC
Matched: Brand · Product details — ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2019
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2019
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2019
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.GE Healthcare, LLC
Matched: Brand · Product details — The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the…
FDA (openFDA device enforcement)
Reported Feb 13, 2019
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific…
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Possible incorrect software version loaded.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Patient monitors may restart due to network overload caused by network configuration.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2018
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation…
FDA (openFDA device enforcement)
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