Z-1479-2009

Philips Avalon Fetal Monitor FM30; Model Number: M2703A

Name: Z-1479-2009 Philips Avalon Fetal Monitor FM30; Model Number: M2703A
Creator: Philips Healthcare Inc.
Published: 2009-05-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-05-12 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips Avalon Fetal Monitor FM30; Model Number: M2703A on 2009-05-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1479-2009
Status: Terminated
Initiated: 2009-05-12
Posted: 2009-06-26
Terminated: 2020-09-23
Recalling firm: Philips North America LLC
Product: Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
Product code: HGM System, Monitoring, Perinatal
Reason for recall: 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 tag: software
FDA 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 in commerce: 4,788 units
Distribution: Worldwide Distribution
Product codes and lots: Units with serial numbers in the range of DE53001002 through DE53107383.

Product code HGM

K071800Class IIPhilips Avalon Fetal Monitors Fm20 and Fm30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN / cleared 2007-09-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)