LIFEPAK 500 AED.

FDA device recall Z-0562-05 · posted 2005-03-10 · Terminated

Recall details

Recalling firm

Medtronic Emergency Response Systems, Inc.

Reason for recall

Potential to not detect patients at the low end of the patient impedance range.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

2,349

Distribution

Devices were distributed to 750 domestic consignees dn 16 international consignees.

Date initiated

2005-02-03

Date posted

2005-03-10

Date terminated

2006-08-21

Location

Redmond, WA