LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003
FDA Recall Z-1107-04 · Posted 2004-07-20
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Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-05-05
Date Terminated2006-05-06
Product Quantity20,676 domestic, 19,899 international
Reason for Recall
Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage.
Firm Action
The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices.
Root Cause
Other
Distribution Pattern
The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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