FDA Medical Device Recalls (openFDA)
Analogic Corporation: FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
- Recall number
- Z-0035-06
- Recalling firm
- Analogic Corporation
- Product
- FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
- Status
- Terminated
- Initiated
- 2005-09-13
- Posted
- 2005-10-12
- Terminated
- 2006-08-07
- 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
- 37 units
- Distribution
- CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 1220672
- Firm city
- Peabody
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28