Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
FDA device recall Z-1479-2009 · posted 2009-06-26 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 4,788 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-05-12
- Date posted
- 2009-06-26
- Date terminated
- 2020-09-23
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K071800) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-09-27 |