FDA Medical Device Recalls (openFDA)
Medtronic Gastroenterology / Urology: Bravo pH Monitoring System Receiver
- Recall number
- Z-0633-04
- Recalling firm
- Medtronic Gastroenterology / Urology
- Product
- Bravo pH Monitoring System Receiver
- Status
- Terminated
- Initiated
- 2004-02-06
- Posted
- 2004-07-20
- Terminated
- 2005-11-21
- Reason
- The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
- Root cause
- Other
- Action
- Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.
- Quantity
- 1468 units
- Distribution
- The devices were distributed nationwide in the United States and worldwide.
- Lot, serial or model codes
- All serial numbers less than 400,000 are involved.
- 510(k) numbers
- ["K002028"]
- PMA numbers
- not on file
- Product code
- FGM
- 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