Recall Z-0115-06 ยท HGM System, Monitoring, Perinatal
Spacelabs Medical Incorporated
BirthNet OB Data Management System 91861
| Date | Nov 1, 2005 (initiated Oct 13, 2005) |
| Status | Terminated |
| Reason | Potential for incorrect weight to be displayed. |
| Root cause | Other |
| Action | 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. |
| Quantity | 44 devices |
| Distribution | Distribution was to 44 medical facilities/hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965008 | BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM Spacelabs Medical, Inc., Dec 16, 1997 |