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FDA Medical Device Recalls (openFDA)

Medtronic Emergency Response Systems, Inc.: Batteries used with the LIFEPAK 20 defibrillator/monitor

Recall number
Z-0887-2007
Recalling firm
Medtronic Emergency Response Systems, Inc.
Product
Batteries used with the LIFEPAK 20 defibrillator/monitor
Status
Terminated
Initiated
2007-03-30
Posted
2007-07-04
Terminated
2011-05-04
Reason
Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
Root cause
Other
Action
Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.
Quantity
3002
Distribution
Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
Lot, serial or model codes
Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266
510(k) numbers
not on file
PMA numbers
not on file
Product code
MJK
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

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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

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