Bravo pH Monitoring System Receiver
FDA device recall Z-0633-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Gastroenterology / 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGM
- Quantity affected
- 1468 units
- Distribution
- The devices were distributed nationwide in the United States and worldwide.
- Date initiated
- 2004-02-06
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-21
- Location
- Shoreview, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO PH MONITORING SYSTEM (K002028) | Endonetics, Inc. | 2000-09-29 |