Z-0633-04

Bravo pH Monitoring System Receiver

Name: Z-0633-04 Bravo pH Monitoring System Receiver
Creator: Medtronic Gastroenterology / Urology
Published: 2004-02-06
License: https://open.fda.gov/license/

Medtronic Gastroenterology / Urology / initiated 2004-02-06 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Gastroenterology / Urology began a recall of Bravo pH Monitoring System Receiver on 2004-02-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0633-04
Status: Terminated
Initiated: 2004-02-06
Posted: 2004-07-20
Terminated: 2005-11-21
Recalling firm: Medtronic Gastroenterology / Urology
Product: Bravo pH Monitoring System Receiver
Product code: FGM Probe And Director, Gastro-Urology
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 1468 units
Distribution: The devices were distributed nationwide in the United States and worldwide.
Product codes and lots: All serial numbers less than 400,000 are involved.

Product code FGM

K002028Class IBravo Ph Monitoring SystemEndonetics, Inc. / cleared 2000-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)