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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Avalon Fetal Monitor

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  Class 2 Device Recall Philips Avalon Fetal Monitor see related information
Date Initiated by Firm May 12, 2009
Date Posted June 26, 2009
Recall Status1 Terminated 3 on September 23, 2020
Recall Number Z-1479-2009
Recall Event ID 52026
510(K)Number K071800  
Product Classification System, monitoring, perinatal - Product Code HGM
Product Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
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
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 4,788 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HGM and Original Applicant = PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
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