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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 12

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 Class 2 Device Recall LIFEPAK 12see related information
Date Initiated by FirmJanuary 15, 2005
Date PostedFebruary 03, 2005
Recall Status1 Terminated 3 on May 06, 2006
Recall NumberZ-0495-05
Recall Event ID 30915
510(K)NumberK040775 K991910 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
ProductLIFEPAK 12 defibrillator/ monitors biphasic
Code Information VLP12-02 Part Numbers all with a Biphasic label on the front of the device
Recalling Firm/
Manufacturer		 Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJohn Parks
425-867-4681
Manufacturer Reason
for Recall		The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
FDA Determined
Cause 2		Software design
ActionThe firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.
Quantity in Commerce28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
Distribution28,835 devices were shipped to 6874 domestic consignees.
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
510(K)s with Product Code = MKJ
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