Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
FDA device recall Z-0087-2009 · posted 2008-10-08 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 214 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-08-22
- Date posted
- 2008-10-08
- Date terminated
- 2009-09-01
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS US (K042607) | Draeger Medical, Inc. | 2004-11-26 |