FDA Device recall Z-1382-2016
GE Healthcare, Aisys Carestation
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of GE Healthcare, Aisys Carestation 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-1382-2016 |
| 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 Carestation.
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 | ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in…ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in device. Device serial number to be provided later) 5395419-1 5395419-2 5395419-3 5405365 5391200-1 5391200-10 5391200-11 5391200-12 5391200-2 5391200-3 5391200-4 5391200-5 5391200-6 5391200-7 5391200-8 5391200-9 5402182 5393755-1 5393755-2 5403569-1 5403569-10 5403569-11 5403569-12 5403569-13 5403569-2 5403569-3 5403569-4 5403569-5 5403569-6 5403569-7 5403569-8 5403569-9 5403570-1 5403570-2 5403570-3 5403570-4 5403570-5 5392643-1 5392643-10 5392643-11 5392643-12 5392643-13 5392643-2 5392643-3 5392643-4 5392643-5 5392643-6 5392643-7 5392643-8 5392643-9 5393856-1 5393856-10 5393856-11 5393856-12 5393856-13 5393856-14 5393856-15 5393856-2 5393856-3 5393856-4 5393856-5 5393856-6 5393856-7 5393856-8 5393856-9 5404595-1 5404595-10 5404595-11 5404595-12 5404595-13 5404595-14 5404595-15 5404595-16 540459 |
|---|
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-1382-2016%22
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