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Terminated

LIFEPAK 500 automated external defibrillator

FDA Recall Z-0886-04 · Posted 2004-07-20

Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-04-02
Date Terminated2005-01-06
Product Quantity7028

Reason for Recall

Potential for batteries to malfunction due to battery cell rupture.

Firm Action

On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.

Root Cause

Other

Distribution Pattern

The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012428MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Physio-Control Corp. · 2001-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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