BirthNet OB Data Management System 91861
FDA device recall Z-0115-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Spacelabs Medical Incorporated
- Reason for recall
- Potential for incorrect weight to be displayed.
- Action taken
- On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.
- Root cause
- Other
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 44 devices
- Distribution
- Distribution was to 44 medical facilities/hospitals nationwide.
- Date initiated
- 2005-10-13
- Date posted
- 2005-11-01
- Date terminated
- 2011-01-17
- 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 |
|---|---|---|
| BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM (K965008) | Spacelabs Medical, Inc. | 1997-12-16 |