Recall Z-1619-2016 ยท FFT Electrode, Ph, Stomach
Covidien LLC
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 softwar
| Date | May 6, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | Potential of an allergic reaction in a patient with nickel sensitivity. |
| Root cause | Device Design |
| Action | The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/2016 to its Customers via Federal Express. The letter describes the product, problem and actions to be taken.The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance MITGFCA@Covidien.com or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo pH monitoring system User Manual and product package insert so t |
| Quantity | 12,895 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002028 | BRAVO PH MONITORING SYSTEM Endonetics, Inc., Sep 29, 2000 |