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U.S. Department of Health and Human Services

Class 2 Device Recall HALO Flex Energy Generators

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 Class 2 Recall
HALO Flex Energy Generators
see related information
Date Posted September 14, 2012
Recall Status1 Terminated on September 30, 2013
Recall Number Z-2379-2012
Recall Event ID 62867
Premarket Notification
510(K) Number
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product HALO Flex Energy Generators Manufactured by B®RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
Code Information Model numbers 1190A-115A and 1190A-230A; all serial numbers.
Recalling Firm/
Covidien LLC
540 Oakmead Pkwy
Sunnyvale, California 94085-4022
For Additional Information Contact Michael W. Doran
Manufacturer Reason
for Recall
Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Action COVIDIEN sent an Urgent Medical Device Correction letter dated August 3, 2012, to all affected customers via Federal Express. Additionally, Field Service Representatives will be contacting their accounts to notify them of the correction.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps prior to initiating patient treatment and specifically, prior to administering conscious sedation and performing upper endoscopy: 1. Power-on the HALO Flex Energy Generator and confirm that the generator passes self-test, enters standby mode and displays "Ready, Connect Catheter." 2. Confirm that the HALO Flex Energy Generator is functioning properly at power-up and enters the standby mode then the procedure can begin. 3. Do not use the HALO Flex Energy Generator if the generator does not pass the power on self-test. In this situation, please call Covidien, GI Solutions customer service at (888) 662-2779 or your local territory manager (sales representative) so that the firm can provide them with a replacemenent generator. 4. Customers were asked to reply to Covidien, GI Solutions (formerly BARRX Medical) by signing and returning the attached Product Correction Form via fax to the number provided on the form. Customers with questions were instructed to call 888-662-2779. For questions regarding this recall call 408-328-7300.
Quantity in Commerce 617 generators
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Jordan, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Venezuela and UK.
Total Product Life Cycle TPLC Device Report

1 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 = GEI and Original Applicant = BARRX MEDICAL, INCORPORATED