Recall Z-0087-2009 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical, Inc.
Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
| Date | Oct 8, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| Reason | Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed. |
| Root cause | Nonconforming Material/Component |
| Action | Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures. |
| Quantity | 214 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042607 | PRIMUS US Draeger Medical, Inc., Nov 26, 2004 |