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Terminated

LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.

FDA Recall Z-0294-04 · Posted 2004-01-06

Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeMKI
Date Initiated2003-11-12
Date Terminated2004-02-25
Product Quantity180 sets

Reason for Recall

Device unable to recognize the connection to the hard paddles accessory.

Firm Action

Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.

Root Cause

Other

Distribution Pattern

The firm distributed devices to 32 hospitals and medical centers located throughout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERMedtronic Physio-Control Corp. · 2002-02-05

Official Source

View FDA Recall →

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

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