Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | HALO Flex Energy Generators Manufactured by BÂRRX 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. |
|---|---|
| Recall Number | Z-2379-2012 |
| Classification | Class II |
| Code Info | Model numbers 1190A-115A and 1190A-230A; all serial numbers. |
| Product Distributed Qty | 617 generators |
| 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. |
Event Detail
| Event Id | 62867 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Covidien LLC |
| City | Sunnyvale |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-03 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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