—#81932

Product

Philips Avalon Fetal Monitor FM30; Model Number: M2703A.

FDA product code: HGM — System, Monitoring, Perinatal
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K071800
Affected lot / code info: Units with serial numbers in the range of DE53001002 through DE53107383.

Why it was recalled

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 (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-05-12
Posted by FDA: 2009-06-26
Terminated: 2020-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.