FDA Medical Device Recalls (openFDA)
Medtronic Emergency Response Systems, Inc.: LIFEPAK EXPRESS defibrillator
- Recall number
- Z-0548-06
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Product
- LIFEPAK EXPRESS defibrillator
- Status
- Terminated
- Initiated
- 2006-01-31
- Posted
- 2006-02-23
- Terminated
- 2011-01-17
- Reason
- One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
- Root cause
- Nonconforming Material/Component
- Action
- On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.
- Quantity
- 20,525 devices total - CR Plus and LIFEPAK Express
- Distribution
- Units were distributed worldwide to public access environments.
- Lot, serial or model codes
- Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
- 510(k) numbers
- not on file
- 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