Recall Z-0966-2012 ยท LLT
Given Imaging Ltd.
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 be attached following either endoscopy or manometry.
| Date | Feb 6, 2012 (initiated Jan 11, 2012) |
| Status | Terminated |
| Reason | Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device. |
| Root cause | Nonconforming Material/Component |
| Action | Given Imaging sent a Urgent Product Recall letter to all affected consignees. The letter identified the product, description of problem, actions to be taken and advised customers to read this important information packet in its entirety. Customers were advised to complete the Customer Response Sheet included and return per the instructions provided. Also attached to the letter was a Customer Bulletin: Update to Vacuum Settings. For questions call 1-800-448-3644 option 3. |
| Quantity | 21,885 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Austria, Belgium, Brazil, Denmark, Canada, Cyprus, Finland, Germany, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Netherlands, Norway, New Zealand, Panama, Portugal, Singapore, Sri Lanka, South Africa, Spain Thailand, Tu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd., Dec 1, 2010 |