Device recall
Z-1619-2016: Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1619-2016 |
|---|---|
| Recall event | 73882 |
| Product | Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age… |
| Product code | FFT |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2017 |
| 510(k) numbers | K002028 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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