Z-0035-06

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

Name: Z-0035-06 FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Creator: Analogic Corporation
Published: 2005-09-13
License: https://open.fda.gov/license/

Analogic Corp. / initiated 2005-09-13 / Terminated

FDA source

Analogic Corporation began a recall of FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring) on 2005-09-13. The reason FDA records is "Unit may not power up due to faulty circuit board". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0035-06
Status: Terminated
Initiated: 2005-09-13
Posted: 2005-10-12
Terminated: 2006-08-07
Recalling firm: Analogic Corp.
Product: FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Product code: HGM System, Monitoring, Perinatal
Reason for recall: Unit may not power up due to faulty circuit board
FDA 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 in commerce: 37 units
Distribution: CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
Product codes and lots: System Serial Numbers: FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005 FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047 FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023 FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114 FA002113 FA002115 FA002026 FA002032 FA001328

Product code HGM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)