FDA Medical Device Recalls (openFDA)
Medtronic Physio Control Corp: LIFEPAK 500 automated external defibrillator
- Recall number
- Z-0886-04
- Recalling firm
- Medtronic Physio Control Corp
- Product
- LIFEPAK 500 automated external defibrillator
- Status
- Terminated
- Initiated
- 2004-04-02
- Posted
- 2004-07-20
- Terminated
- 2005-01-06
- Reason
- Potential for batteries to malfunction due to battery cell rupture.
- Root cause
- Other
- Action
- On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.
- Quantity
- 7028
- Distribution
- The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, United Kingdom.
- Lot, serial or model codes
- Part numbers 3005380-000 through 3005380-006 and 3005380-014 Serial numbers may be obtained from the firm or from Seattle District Recall Coordinator. All battery date codes prior to 0013
- 510(k) numbers
- ["K012428"]
- 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