Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use wit
FDA device recall Z-0776-2012 · posted 2012-01-17 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- One Spacelabs Medical Ultraview SL Command Module, Model 91496, was removed from customer due to software error.
- Action taken
- Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- one unit
- Distribution
- One device distributed in Troy, MI.
- Date initiated
- 2011-07-13
- Date posted
- 2012-01-17
- Date terminated
- 2012-01-20
- 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 MULTI-PARAMETER MODULE (K103142) | Spacelabs Healthcare, Inc. | 2011-03-03 |