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Terminated

LIFEPAK CR Plus defibrillator

FDA Recall Z-0940-03 · Posted 2003-06-12

Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeMKJ
Date Initiated2003-05-23
Date Terminated2004-02-24
Product Quantity7095 devices

Reason for Recall

Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.

Firm Action

On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.

Root Cause

Other

Distribution Pattern

The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011144LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Physio-Control Corp. · 2001-12-03

Official Source

View FDA Recall →

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

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