HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatur...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0278-2013.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0278-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0278-2013.
Terumo Cardiovascular Systems Corporation
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Terumo Cardiovascular Systems Corporation Recall FAQ
Terumo Cardiovascular Systems Corporation is the subject of a medical devices safety report: HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperatur.... The notice was published on October 16, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 19 units are potentially affected.