FDA Medical Device Recalls (openFDA)
Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defbrillator/monitor
- Recall number
- Z-0984-05
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Product
- LIFEPAK 20 defbrillator/monitor
- Status
- Terminated
- Initiated
- 2005-06-17
- Posted
- 2005-07-13
- Terminated
- 2006-05-06
- Reason
- The defibrillator may not operate if the device is turned on during an AC Loss Alert.
- Root cause
- Other
- Action
- On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.
- Quantity
- 3924 units
- Distribution
- Devices were distributed to hospitals and medical centers worldwide.
- Lot, serial or model codes
- Various, noncontiguous serial numbers. Part numbers: 3202487-xxxd and 3202488-xxx.
- 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