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Class 2 Device Recall Philips |
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Date Initiated by Firm |
December 15, 2004 |
Date Posted |
December 21, 2004 |
Recall Status1 |
Terminated 3 on February 02, 2016 |
Recall Number |
Z-0341-05 |
Recall Event ID |
30666 |
510(K)Number |
K031187
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Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
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Product |
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use) |
Code Information |
Software versions A.02.00 and lower |
Recalling Firm/ Manufacturer |
Philips Medical Systems 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact |
Brenda Getchell 978-659-2134
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Manufacturer Reason for Recall |
In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
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FDA Determined Cause 2 |
Other |
Action |
Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative. |
Quantity in Commerce |
2520 units |
Distribution |
Nationwide
Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen |
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 = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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