Class 2 Device Recall HALO Flex Energy Generators

• Date Initiated by Firm: August 03, 2012
• Date Posted: September 14, 2012
• Recall Status: Terminated on September 30, 2013
• Recall Number: Z-2379-2012
• Recall Event ID: 62867
• 510(K)Number: K092487
• 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/ Manufacturer: Covidien LLC; 540 Oakmead Pkwy; Sunnyvale CA 94085-4022
• For Additional Information Contact: Michael W. Doran; 408-328-7300
• 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.
• FDA Determined Cause: Software design
• 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 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 = GEI and Original Applicant = BARRX MEDICAL, INCORPORATED