HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HAL
FDA device recall Z-2379-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- 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 taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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
- Date initiated
- 2012-08-03
- Date posted
- 2012-09-14
- Date terminated
- 2013-09-30
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A (K092487) | Barrx Medical, Incorporated | 2009-11-10 |