GE Healthcare Recalls Aestiva/5 MRI Anesthesia Systems Due to Flow Sensor Defect
GE Healthcare is recalling two Aestiva/5 MRI Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare, LLC is recalling two Aestiva/5 MRI Anesthesia Systems. The recall is due to a defect where flow sensors could have damaged tubes in the form of small punctures or cuts.
The affected devices are those with installed flow sensors with an etched manufacturing date of August 2020. These systems are designed to provide anesthesia functionality in magnetic resonance (MR) environments.
The product was distributed in numerous U.S. states, including Alabama, Arizona, California, and Texas, as well as in foreign countries such as Australia, Canada, France, and the United Kingdom. Users should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 2
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · tube damage
See all →- HighGE Healthcare anesthesia machine flow sensors may over-deliver anesthetic
FDA (Devices) · 2021-10-06
- HighAnesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks
FDA (Devices) · 2021-10-06
- HighGE Healthcare Recalls 9100c NXT Systems Due to Flow Sensor Defects
FDA (Devices) · 2020-11-11