Device 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. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Z-1619-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,895 units
- Official record key
device-enforcement:Z-1619-2016
Official wording
Reason: Potential of an allergic reaction in a patient with nickel sensitivity.
Code information: All lot numbers
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.
Derived failure modes
-
Unknown
Potential of an allergic reaction in a patient with nickel sensitivity.