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Terminated

FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)

FDA Recall Z-0035-06 · Posted 2005-10-12

Recalling FirmAnalogic Corporation
Recall StatusTerminated
Product CodeHGM
Date Initiated2005-09-13
Date Terminated2006-08-07
Product Quantity37 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.

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