Medtronic Emergency Response Systems, Inc. LIFEPAK 12 defibrillator/ monitors biphasic Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LIFEPAK 12 defibrillator/ monitors biphasic
Brand
Medtronic Emergency Response Systems, Inc.
Lot Codes / Batch Numbers
VLP12-02 Part Numbers all with a Biphasic label on the front of the device
Products Sold
VLP12-02 Part Numbers all with a Biphasic label on the front of the device
Medtronic Emergency Response Systems, Inc. is recalling LIFEPAK 12 defibrillator/ monitors biphasic due to The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026