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U.S. Department of Health and Human Services

Class 1 Device Recall LIFEPAK

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  Class 1 Device Recall LIFEPAK see related information
Date Initiated by Firm February 03, 2005
Date Posted March 10, 2005
Recall Status1 Terminated 3 on August 21, 2006
Recall Number Z-0562-05
Recall Event ID 31111
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product LIFEPAK 500 AED.
Code Information Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX
Recalling Firm/
Manufacturer		 Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact John A. Parks
425-867-4681
Manufacturer Reason
for Recall		 Potential to not detect patients at the low end of the patient impedance range.
FDA Determined
Cause 2		 Device Design
Action On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.
Quantity in Commerce 2,349
Distribution Devices were distributed to 750 domestic consignees dn 16 international consignees.
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.
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