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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical Systems

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  Class 2 Device Recall Philips Medical Systems see related information
Date Initiated by Firm April 29, 2005
Date Posted May 17, 2005
Recall Status1 Terminated 3 on September 14, 2010
Recall Number Z-0848-05
Recall Event ID 31955
510(K)Number K031187  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Philips Medical HeartStart MRx Monitor/Defibrillator
Model: M3535A, M3536A
Code Information Software Versions A.03.00 or lower and B.04.00 and lower
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810-1032
For Additional Information Contact
978-659-1500
Manufacturer Reason
for Recall		 The device may disarm and not deliver shock when performing a Synchronized Cardioversion
FDA Determined
Cause 2		 Software design
Action Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.
Quantity in Commerce 5125 units
Distribution Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen
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 = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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