Recall Z-0633-04 ยท FGM Probe And Director, Gastro-Urology
Medtronic Gastroenterology / Urology
Bravo pH Monitoring System Receiver
| Date | Jul 20, 2004 (initiated Feb 6, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002028 | BRAVO PH MONITORING SYSTEM Endonetics, Inc., Sep 29, 2000 |