FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
FDA Recall Z-0036-06 · Posted 2005-10-12
Recalling FirmAnalogic Corporation
Recall StatusTerminated
Product CodeHGM
Date Initiated2005-09-13
Date Terminated2006-08-07
Product Quantity13 units
Reason for Recall
Unit may not power up due to faulty circuit board
Firm 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.
Root Cause
Other
Distribution Pattern
CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.