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U.S. Department of Health and Human Services

Class 2 Device Recall automated external defibrillator

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 Class 2 Device Recall automated external defibrillatorsee related information
Date Initiated by FirmOctober 01, 2009
Date PostedDecember 08, 2009
Recall Status1 Terminated 3 on September 27, 2013
Recall NumberZ-0062-2010
Recall Event ID 53383
510(K)NumberK051632 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductHeartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Code Information The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and  AC4=Portugal.  Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement. 
Recalling Firm/
Manufacturer		 Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
For Additional Information ContactGeorge Biggins
206-664-5215
Manufacturer Reason
for Recall		A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
Quantity in Commercesee Z-0063-2010
DistributionDomestic and Worldwide distribution to: United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MKJ
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