Recall archive
353 recalls · page 6 of 15
Reported Jan 29, 2020
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2020
CARESCAPE Respiratory Module E-sCO
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2020
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details — When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro…
2 more products in this recall
FDA (openFDA device enforcement)
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 16, 2019
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ohmeda Medical
Matched: Reason for recall — GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals…
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 31, 2019
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when…
1 more product in this recall
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 Jun 5, 2019
Horizon Cardiology Hemo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Israel Ltd.
Matched: Brand — users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in…
1 more product 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 17, 2019
Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medi-Physics Inc. dba GE Healthcare
Matched: Brand · Product details — Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
FDA (openFDA drug enforcement)
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