FDA Medical Device Recalls (openFDA)
Medtronic Emergency Response Systems, Inc.: LIFEPAK 12 defibrillator/ monitors biphasic
- Recall number
- Z-0495-05
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Product
- LIFEPAK 12 defibrillator/ monitors biphasic
- Status
- Terminated
- Initiated
- 2005-01-15
- Posted
- 2005-02-03
- Terminated
- 2006-05-06
- Reason
- The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
- Root cause
- Software design
- 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.
- Quantity
- 28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
- Distribution
- 28,835 devices were shipped to 6874 domestic consignees.
- Lot, serial or model codes
- VLP12-02 Part Numbers all with a Biphasic label on the front of the device
- 510(k) numbers
- ["K040775","K991910"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28