Recall Z-0648-2010 ยท DXJ Display, Cathode-Ray Tube, Medical
Spacelabs Healthcare, Incorporated
Spacelabs Model 91369-24 SL 2400 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 | 2,023 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 |