GE Anesthesia Systems Base Cracking and Fall Hazard Recalled
GE Healthcare anesthesia systems may develop cracks in the base, potentially causing the device to tip and fall. The FDA recalled 667 units distributed across multiple U.S. states and countries.
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: This is an FDA Class II recall of a medical device with a structural defect (cracking base) that could cause the system to tip or fall and result in injury. No illnesses or injuries have been reported to date, and the hazard is potential rather than documented.
Plain-English summary
GE Healthcare has recalled Avance CS2, Avance CS2 Pro, and Aisys CS2 anesthesia systems due to a structural hazard affecting 667 devices.
The base of these anesthesia systems can develop cracks and potentially fracture. If the base fails, the system may tip or overbalance, creating a risk that the device could fall and injure patients or staff.
The recalled systems were distributed to hospitals and anesthesia facilities in 28 U.S. states and to military locations, as well as internationally. This is an FDA Class II recall.
The recalled product
- Product
- GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 667
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 (4)
- Avance CS2 and Avance CS2 Pro - GTIN 00840682102322
- all serial numbers
- Aisys CS2 - GTIN 00840682102292
- all serial numbers.
Distribution
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