Recall Z-2379-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Covidien LLC
HALO Flex Energy Generators Manufactured by BRRX 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 Esopha
| Date | Sep 14, 2012 (initiated Aug 3, 2012) |
| Status | Terminated |
| Reason | Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. |
| Root 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 |
| Quantity | 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, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A Barrx Medical, Incorporated, Nov 10, 2009 |