Recall Z-0649-2010 ยท DXJ Display, Cathode-Ray Tube, Medical
Spacelabs Healthcare, Incorporated
Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
| Date | Jan 19, 2010 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | Potential for monitor to shut down and not being able to power on again. |
| Root cause | Component design/selection |
| Action | On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x |
| Quantity | 968 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972282 | SPACELABS MEDICAL PCIS PATIENT MONITORS Spacelabs Medical, Inc., Sep 25, 1997 |