FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
FDA device recall Z-0035-06 · posted 2005-10-12 · Terminated
Recall details
- Recalling firm
- Analogic Corporation
- Reason for recall
- Unit may not power up due to faulty circuit board
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 37 units
- Distribution
- CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
- Date initiated
- 2005-09-13
- Date posted
- 2005-10-12
- Date terminated
- 2006-08-07
- Location
- Peabody, MA
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