Z-0562-05

Lifepak 500 AED

Name: Z-0562-05 Lifepak 500 AED
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2005-02-03
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2005-02-03 / Terminated / root cause: design

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK 500 AED on 2005-02-03. The reason FDA records is "Potential to not detect patients at the low end of the patient impedance range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0562-05
Status: Terminated
Initiated: 2005-02-03
Posted: 2005-03-10
Terminated: 2006-08-21
Recalling firm: Physio Control, Inc.
Product: Lifepak 500 AED.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Potential to not detect patients at the low end of the patient impedance range.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)