Recall Z-0036-06 ยท HGM System, Monitoring, Perinatal
Analogic Corporation
FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
| Date | Oct 12, 2005 (initiated Sep 13, 2005) |
| Status | Terminated |
| Reason | Unit may not power up due to faulty circuit board |
| Root cause | Other |
| Action | Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board. |
| Quantity | 13 units |
| Distribution | CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.