FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
- Recall number
- Z-1479-2009
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
- Status
- Terminated
- Initiated
- 2009-05-12
- Posted
- 2009-06-26
- Terminated
- 2020-09-23
- Reason
- Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions
- Root cause
- Software change control
- Action
- Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade. Questions can be made to Philips response center at 1-800-722-9377.
- Quantity
- 4,788 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Units with serial numbers in the range of DE53001002 through DE53107383.
- 510(k) numbers
- ["K071800"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 1218950
- Firm city
- Andover
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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