FDA Device recall Z-2379-2012
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085 by Covidien, citing potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2379-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model numbers 1190A-115A and 1190A-230A; all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2379-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.