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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Avalon Monitors

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  Class 2 Device Recall Philips Avalon Monitors see related information
Date Initiated by Firm October 03, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on January 31, 2017
Recall Number Z-0105-2015
Recall Event ID 69348
510(K)Number K111083  
Product Classification System, monitoring, perinatal - Product Code HGM
Product Philips Avalon Monitors with software revision J.30.58:

Model Product
FM20 M2702A ;
FM30 M2703A ;
FM50 M2705A

Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Code Information software revision J.30.58:   
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Same
978-687-1501
Manufacturer Reason
for Recall		 Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
FDA Determined
Cause 2		 Software Design Change
Action Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: During the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. Please review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.
Quantity in Commerce 118 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.
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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