Recall Z-1512-2024 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Drger Perseus A500 Anesthesia Workstation
| Date | Apr 18, 2024 (initiated Mar 20, 2024) |
| Status | Open, Classified |
| Reason | Unexpected shutdown while operating on battery power. |
| Root cause | Labeling design |
| Action | Consignees were sent an Urgent Medical Device Recall notification by mail on 3/20/24. The notice informs consignees of the possibility of device shutdown with possible loss of ventilation, which consignees are instructed to either use an emergency ventilation bag or apply manual ventilation with the Perseus with the provided instructions. Consignees are to perform a battery test on all affected devices in their inventory per the provided instructions in the recall notification. If the tested unit(s) fails the battery test, consignees are to contact Drager Service Technical Support between 8:00 |
| Quantity | 16,841 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133886 | PERSEUS A500 Draeger Medical GmbH, Jun 20, 2014 |