FDA Device recall Z-1381-2016
GE Healthcare, Aisys CS2 anesthesia
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of GE Healthcare, Aisys CS2 anesthesia by Ge Medical Systems, citing GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgrad….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1381-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-17 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI |
Product
GE Healthcare, Aisys CS2 anesthesia..
Reason
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
Identifiers
| code_info | APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU02682 APWU02683 APWU02684 APWU02685 APWU02686 APWU02687…APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU02682 APWU02683 APWU02684 APWU02685 APWU02686 APWU02687 APWU02688 APWU02689 APWU02690 APWU02691 APWU02692 APWU02693 APWU02694 APWU02695 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU02708 APWT02996 APWT02384 APWT02254 APWT02255 APWT02256 APWT02257 APWT02258 APWT03126 APWT03127 APWT02326 APWU02707 APWT00391 APWT00392 APWT00393 APWT00394 APWT00395 APWU01576 APWU01577 APWU01578 APWU00363 APWU00364 APWU00365 APWU00366 APWT00898 APWT00899 APWT02417 APWV00144 APWU00707 APWU00708 APWU00709 APWU00710 APWU00711 APWU02287 APWU00190 APWU02166 APWU02167 APWU02168 APWU02169 APWU02170 APWU02171 APWU02172 APWU02316 APWU02317 APWU02318 APWU02319 APWU02320 APWU02321 APWU02322 APWT02043 APWT02044 APWT02045 APWT02046 APWT02047 APWT02048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1381-2016%22
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