FDA Medical Device Recalls (openFDA)
Medtronic Emergency Response Systems, Inc.: standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
- Recall number
- Z-0117-06
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Product
- standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
- Status
- Terminated
- Initiated
- 2005-09-02
- Posted
- 2005-11-02
- Terminated
- 2011-01-17
- Reason
- Potential for voltage pins in connector of therapy cable to break.
- Root cause
- Other
- Action
- On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,
- Quantity
- not on file
- Distribution
- Devices were distributed worldwide.
- Lot, serial or model codes
- Standard Hard Paddles part number: 3006228-013 and below
- 510(k) numbers
- ["K012274"]
- PMA numbers
- not on file
- Product code
- LDD
- 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