GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits
GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a critical failure in a life-support medical device (anesthesia system) that could result in serious injury or death if backup ventilation is not provided, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
GE Healthcare, LLC is recalling 4,207 touchscreen display kits for the GE Datex-Ohmeda Aisys Anesthesia System. The affected units are distributed worldwide, including in the United States and numerous international markets. The kits are sold under various product names, such as TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, and are identified by specific model and serial numbers listed in the recall notice.
The recall is due to a software defect in the PSVPro Spontaneous Breathing Modes. Specifically, the devices do not provide the feature of transitioning to SIMV PCV backup ventilation mode if a patient stops spontaneous breathing while the PSVPro mode is in use prior to the clinician starting the Cycling Procedure. This failure could prevent the device from providing necessary ventilatory support in critical situations.
The Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients, including neonatal, pediatric, and adult patients. The device is intended for volume or pressure control ventilation. Users should check their device serial numbers against the list provided by the FDA and contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 4,207
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number
- UDI Number
- (Serial Number): 2097673-001-US (4651698-1)
- 2097673-001-US (4651698-3)
- 2097673-001-US (4651698-4)
- 2097673-001-US (4651726-1)
- 2097673-001-US (4652206-1)
- 2097673-001-US (4652206-2)
- 2097673-001-US (4649618-1)
- 2097673-001-US (4649618-2)
- 2097673-001-US (4649618-3)
- 2097673-001-US (4649618-4)
- 2097673-001-US (4649618-5)
- 2097673-001-US (4653227-1)
- 2097673-001-US (4653227-2)
- 2097673-001-US (4653227-3)
- 2097673-001-US (5474296-1)
- 2097673-001-US (4652587-1)
- 2097673-001-US (4652587-2)
- 2097673-001-US (4652587-3)
Distribution
Part of a larger recall action
This product is one of 3 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 3 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
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
Same hazard · ventilation failure
See all →- SevereGE Healthcare Carestation 650 A1 Anesthesia System Ventilation
FDA (Devices) · 2025-05-07
- SevereGE Healthcare CARESTATION Anesthesia Systems Volume Control Ventilation Failure
FDA (Devices) · 2025-05-07
- SevereGE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall
FDA (Devices) · 2025-05-07
- SevereGE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure
FDA (Devices) · 2025-05-07
- SevereGE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall
FDA (Devices) · 2025-05-07
Similar recalls
- SevereGE Aisys Anesthesia System Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27
- HighGE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect
FDA (Devices) · 2016-01-27
- HighGE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect
FDA (Devices) · 2016-05-04
- HighGE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors
FDA (Devices) · 2020-11-11
- HighGE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27
- SevereGE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons
FDA (Devices) · 2013-10-23