Spacelabs flat panel monitor, Model 91415-A
FDA device recall Z-0269-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda, Inc.
- Reason for recall
- Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
- Action taken
- A letter dated October 31, 2003 was sent on October 29-31, 2003 to all US customers via FED-EX. An ORDER FORM accompanied the letter for consignees to request a replacement power supply or to indicate they did not have the affected power supply.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 2734 units for domestic consignees and 1099 for international consignees
- Distribution
- The firm distributes to hospitals nationwide. The firm also distributes internationally.
- Date initiated
- 2003-10-29
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-17
- Location
- Issaquah, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY (K932724) | Spacelabs Medical, Inc. | 1993-11-05 |