Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively
FDA device recall Z-1608-2015 · posted 2015-05-13 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
- Action taken
- The firm sent the Urgent Medical Device Correction- Spacelabs Healthcare Inc.-qube Compact Monitor, Model 91390, Power Input PCBA Failure letter, dated 8 May 2015, via priority service mail to US consignees. This letter described the affected system, problem, actions to be taken by users and corrective actions conducted by Spacelabs. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 5 units distributed in the US
- Distribution
- distributed in North Carolina, Texas, and Wyoming
- Date initiated
- 2015-05-08
- Date posted
- 2015-05-13
- Date terminated
- 2015-11-05
- Location
- Snoqualmie, 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 HEALTHCARE QUBE COMPACT MONITOR (91390 (K120616) | Spacelabs Medical, Inc. | 2012-03-29 |