FDA Medical Device Recalls (openFDA)
Medtronic Gastroenterology / Urology: Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
- Recall number
- Z-0924-04
- Recalling firm
- Medtronic Gastroenterology / Urology
- Product
- Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
- Status
- Terminated
- Initiated
- 2004-04-28
- Posted
- 2004-07-20
- Terminated
- 2005-11-21
- Reason
- Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
- Root cause
- Other
- Action
- Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.
- Quantity
- 42 units
- Distribution
- The devices were distributed nationwide in the United States.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K981733"]
- PMA numbers
- not on file
- Product code
- FFX
- Firm FEI
- 1000135098
- Firm city
- Shoreview
- Firm state
- MN
- 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