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U.S. Department of Health and Human Services

Class 2 Device Recall Bravo pH Monitoring capsule

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  Class 2 Device Recall Bravo pH Monitoring capsule see related information
Date Initiated by Firm January 11, 2012
Date Posting Updated February 06, 2012
Recall Status1 Terminated 3 on September 14, 2012
Recall Number Z-0966-2012
Recall Event ID 61018
510(K)Number K102543  
Product Classification Monitor, fetal ph - Product Code LLT
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 be attached following either endoscopy or manometry.
Code Information FGS-0312 (5 pack), Lot numbers: 11775Q, 12064Q, 12227Q, 12333Q, 12389Q, 12440Q, 12475Q, 12494Q, 12643Q, 12545Q, 12769Q, 12770Q, 12840Q, 12896Q, 12897Q, 12928Q, 12989Q, 13026Q, 13056Q, 13109Q, 13109Q, 13162Q, 13164Q, 13208Q, 13233Q, 13246Q, 13282Q, 13283Q, 13371Q, 13390Q, 13462Q, 13461Q, 13540Q, 13569Q, 13634Q, 13679Q, 13695Q, 13700Q, 13712Q, 13716Q, 13753Q, 13777Q, 13786Q, 13798Q, 13799Q, 13813Q, 13836Q, 13867Q, 13894Q, 13937Q, 13979Q, 14064Q, 14101Q, 14120Q, 14141Q, 14230Q, 14255Q, 14265Q, 14284Q, 14338Q, 14400Q, 14419Q, 14423Q, 14458Q, 14491Q, 14542Q, 1457QQ, 14572Q, 14570Q, 14611Q, 14634Q, 14734Q, 14770Q, 14805Q, 14825Q, 14826Q, 14871Q, 15030Q, 15051Q, 15071Q, 15078Q, 15114Q, 15158Q, 15221Q, 15324Q, 15406Q, 15401Q, 15500Q, 15603Q, 15630Q, 15672Q, 15679Q, 15711Q, 15787Q, 15860Q, 15912Q, 15938Q, 15971Q, 15998Q, 16115Q, 16144Q, 16192Q, 16221Q, 16320Q, 16290Q, 16354Q, 16382Q, 16395Q, 16449Q, 16503Q, 16511Q, 16580Q, 16606Q, 16607Q, 16673Q, 16762Q, 16867Q, 16762Q & 16847Q and FGS-0313 (single pack), Lot numbers: 12647Q, 12765Q, 12797Q, 12902Q, 13234Q, 13458Q, 13608Q, 13632Q, 13635Q, 13751Q, 13868Q, 13907Q, 14011Q, 14065Q, 14231Q, 14339Q, 14402Q, 14612Q, 14761Q, 14783Q, 14865Q, 14984Q, 15222Q, 15538Q, 15698Q, 15766Q, 15937Q, 16392Q, 16194Q, 16398Q, 16707Q, 16879Q, 17058Q & 16912Q. Recall expanded on 02/20/2012 to include additional lot numbers: 17102Q, 17188Q and 17227Q.
Recalling Firm/
Given Imaging Ltd.
5555 Oakbrook Pkwy
Norcross GA 30093-6254
For Additional Information Contact Tim Thoams
770-662-0870 Ext. 106
Manufacturer Reason
for Recall
Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
FDA Determined
Cause 2
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 in Commerce 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, Turkey, United Kingdom and Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLT and Original Applicant = GIVEN IMAGING LTD.