LIFEPAK 12 defibrillator/monitor
FDA Recall Z-0710-06 · Posted 2006-04-04
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Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2006-03-22
Date Terminated2011-09-06
Product Quantity942 devices
Reason for Recall
Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
Firm Action
On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
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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