FDA Medical Device Recalls (openFDA)
Analogic Corporation: FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
- Recall number
- Z-0036-06
- Recalling firm
- Analogic Corporation
- Product
- FETALGARD Lite Fetal Monitors, Model HCS (Home Care 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
- 13 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
- Serial Numbers: FA002010 FA002051 FA002054 FA002059 FA002061 FA002062 FA002064 FA002011 FA002013 FA002014 FA002056 FA002065 FA002058
- 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