FDA Medical Device Recalls (openFDA)
Medtronic Physio Control Corp: LIFEPAK CR Plus defibrillator
- Recall number
- Z-0940-03
- Recalling firm
- Medtronic Physio Control Corp
- Product
- LIFEPAK CR Plus defibrillator
- Status
- Terminated
- Initiated
- 2003-05-23
- Posted
- 2003-06-12
- Terminated
- 2004-02-24
- Reason
- Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
- Root cause
- Other
- Action
- On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.
- Quantity
- 7095 devices
- Distribution
- The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.
- Lot, serial or model codes
- All serial numbers below 31058753
- 510(k) numbers
- ["K011144"]
- 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