GE Healthcare, LLC recalls Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3)…
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of…
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- GE Healthcare
- Product
- Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3)…
- Classification
- Class II
- Units
- Distribution was nationwide, including PR. Foreign distribution was made to…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More GE Healthcare recalls
- 2022-02-02
USGE Healthcare, LLC recalls GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
FDA · DeviceGE Healthcare, LLCDomestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →- 2021-12-08
- US
GE Healthcare, LLC recalls GE Centricity Universal Viewer Zero Footprint Client
There is a potential to display incomplete patient imaging study.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - 2021-12-01
- US
GE Healthcare, LLC recalls Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the…
- 2021-10-27
- US
GE Healthcare, LLC recalls SIGNA Pioneer nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDA · DeviceGE Healthcare, LLCDistribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH,…Official notice → - 2021-10-13
- US
GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
FDA · DeviceGE Healthcare, LLCAR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France,…Official notice → - 2021-10-06
- US
GE Healthcare, LLC recalls AMX Navigate Mobile X-Ray System
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Other drugs & medical recalls in the United States
- 2021-10-06
- US
Corin Ltd recalls Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT,…Official notice → - US
Beckman Coulter Inc. recalls DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH,…Official notice → - US
Hill-Rom, Inc. recalls LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The…
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may…
FDA · DeviceHill-Rom, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in…
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.Official notice → - US
Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - US
Elekta, Inc. recalls MOSAIQ Oncology Information System
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA · DeviceElekta, Inc.Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH,…Official notice →