LIFEPAK 12 defibrillator/ monitors biphasic
FDA Recall Z-0495-05 · Posted 2005-02-03
Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-01-15
Date Terminated2006-05-06
Product Quantity28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
Reason for Recall
The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
Firm Action
The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.
Root Cause
Software design
Distribution Pattern
28,835 devices were shipped to 6874 domestic consignees.
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.