LIFEPAK 12 defibrillator/ monitors biphasic
This recall has been terminated (originally issued February 3, 2005).
- Recall Initiated
- January 15, 2005
- Posted
- February 3, 2005
- Terminated
- May 6, 2006
- Recall Number
- Z-0495-05
- Quantity
- 28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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.
Distribution
28,835 devices were shipped to 6874 domestic consignees.
Lot / Code Info
VLP12-02 Part Numbers all with a Biphasic label on the front of the device
Root Cause
Software design
Action Taken
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.