Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
FDA Recall Z-1479-2009 · Posted 2009-06-26
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeHGM
Date Initiated2009-05-12
Date Terminated2020-09-23
Product Quantity4,788 units
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
Firm 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.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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