Perseus A500 Anesthesia Workstation — Class I medical device recall Z-0360-2016
Terminated recall by Draeger Medical, Inc., reported 2015-12-23, distributed in IL, ME, NY, OH, PA, WI. There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The
| Recall number | Z-0360-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2015-11-12 |
| Classified | 2015-12-11 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-04-05 |
| Distributed | IL, ME, NY, OH, PA, WI |
| Quantity | 34 |
Product
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
Reason for recall
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0360-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.