Z-2379-2012Class II

HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA...

Name: Z-2379-2012 HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA...
Creator: Covidien LLC
Published: 2012-08-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-08-03 / Terminated / root cause: software

FDA source

Covidien LLC began a recall of HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated... on 2012-08-03. FDA classified it as Class II and gives the reason as "Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2379-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Posted: 2012-09-14
Terminated: 2013-09-30
Recalling firm: Medtronic, Inc.
Product: 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 Esophagus.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: Model numbers 1190A-115A and 1190A-230A; all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2379-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2379-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14

Product code GEI

K092487Class IIHaloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated / cleared 2009-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)