FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
- Recall number
- Z-0279-2013
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
- Status
- Terminated
- Initiated
- 2012-10-16
- Posted
- 2012-11-13
- Terminated
- 2013-07-11
- Reason
- Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up
- Root cause
- Nonconforming Material/Component
- Action
- TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.
- Quantity
- 15 units
- Distribution
- Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
- Lot, serial or model codes
- Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05.
- 510(k) numbers
- K071521
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28