HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system...
Terumo Cardiovascular Systems Corporation began a recall of HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0278-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- HX2 Temp Manage SYS 120V 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.
- Product code
- DWC Controller, Temperature, Cardiopulmonary Bypass
- Reason for recall
- 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 tag
- manufacturing process
- FDA 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 in commerce
- 19 units
- Distribution
- Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
- Product codes and lots
- Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0278-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0279-2013 | Class II | Terminated | Voluntary: Firm initiated |
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