Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is
FDA device recall Z-1705-2014 · posted 2014-06-03 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
- Action taken
- Spacelabs Healthcare identified a software anomaly in the Ultraview SL" Command Module, Model 91496. During an internal audit, Spacelabs identified a reportable recall that was not reported. We have a product called the Spacelabs Medical Ultraview SL" Command Module, Model 91496. A software error was discovered at a customer site which was not a safety issue, but in the interest of customer service it was decided to downgrade all their modules with an older software version.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 64 devices
- Distribution
- US Distribution to GA.
- Date initiated
- 2014-05-08
- Date posted
- 2014-06-03
- Date terminated
- 2014-06-03
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MULTI-PARAMETER MODULE (K103142) | Spacelabs Healthcare, Inc. | 2011-03-03 |