Device recall
Z-0966-2012: Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688…
FDA device recall · Class II · Given Imaging Ltd.
Key facts
| Recall number (Z-number) | Z-0966-2012 |
|---|---|
| Recall event | 61018 |
| Product | Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can… |
| Product code | LLT |
| Recalling firm | Given Imaging Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2012 |
| 510(k) numbers | K102543 |
| FEI number | 3003141635 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database