Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from S
FDA device recall Z-0649-2010 · posted 2010-01-19 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- Potential for monitor to shut down and not being able to power on again.
- Action taken
- 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 x5089 for those customers outside of the US.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 968 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-11-06
- Date posted
- 2010-01-19
- Date terminated
- 2011-07-21
- 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 PCIS PATIENT MONITORS (K972282) | Spacelabs Medical, Inc. | 1997-09-25 |