GE Healthcare Recalls Aisys Anesthesia Systems for Missing Backup Ventilation Feature
GE Healthcare is recalling Aisys anesthesia systems because a software upgrade prevents the device from automatically switching 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could prevent automatic backup ventilation, posing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
GE Healthcare, LLC is recalling 4,207 Aisys Anesthesia Systems and Aisys CS2 anesthesia devices. The recall involves specific model numbers and serial numbers, including units sold under various product names such as AISYS and AISYS 10.X TO 11.X UPGRADE KITS in multiple languages.
The recall is due to a software defect in devices that have been upgraded with PSVPro Spontaneous Breathing Modes. These devices do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. Specifically, if a patient stops spontaneous breathing while the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure, the device will not automatically transition to the backup ventilation mode.
The affected devices were distributed worldwide, including in the United States and numerous international countries. No illnesses or injuries have been reported in the source text. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN…
- 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): 2097674-001-US
- Not Applicable
- (5470345-30)
- 2097674-001-US
- (5470345-31)
- (5470345-32)
- 1011-9000-000
- (ANAK00774)
- (ANAK00775)
- (ANAL01201)
- (ANAL01234)
- (ANAL01235)
- (ANAL01236)
- (ANAL01237)
- (ANAL01238)
- (ANAL01240)
- (ANAL01494)
- (ANAL01495)
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.
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