Drug recall
GE Healthcare, Aisys Carestation.
FDA recall event 73383 · Class II · GE Medical Systems, LLC
Key facts
| Event ID | 73383 |
|---|---|
| Recall numbers | Z-1381-2016, Z-1382-2016 |
| Recalling firm | GE Medical Systems, LLC |
| Product type | Devices |
| Products | GE Healthcare, Aisys Carestation., GE Healthcare, Aisys CS2 anesthesia.. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Feb 17, 2016 |
| Report date | Apr 20, 2016 |
| Termination date | Sep 4, 2018 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: