Recall Z-0269-04 ยท DXJ Display, Cathode-Ray Tube, Medical
Datex-Ohmeda, Inc.
Spacelabs flat panel monitor, Model 91415-A
| Date | Jul 20, 2004 (initiated Oct 29, 2003) |
| Status | Terminated |
| Reason | Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2734 units for domestic consignees and 1099 for international consignees |
| Distribution | The firm distributes to hospitals nationwide. The firm also distributes internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY Spacelabs Medical, Inc., Nov 5, 1993 |