Date Initiated by Firm | May 12, 2009 |
Date Posted | June 26, 2009 |
Recall Status1 |
Terminated 3 on September 23, 2020 |
Recall Number | Z-1478-2009 |
Recall Event ID |
52026 |
510(K)Number | K071800 |
Product Classification |
System, monitoring, perinatal - Product Code HGM
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Product | Philips Avalon Fetal Monitor FM20; Model Number: M2702A. |
Code Information |
Units with serial numbers in the range of DE53001002 through DE53107383. |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact | 978-687-1501 |
Manufacturer 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 |
FDA Determined Cause 2 | 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 | 5,663 units |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HGM
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