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Terminated

Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine

FDA Recall Z-0350-2007 · Posted 2007-01-25

Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeDWC
Date Initiated2006-11-10
Date Terminated2007-02-05
Product Quantity13 units

Reason for Recall

The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.

Firm Action

Letters were mailed to customers on 11/10/2006 by Federal Express.

Root Cause

Other

Distribution Pattern

Hospitals in CA, NC, FL, WY, NY and WV.S

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031544HEATER COOLER UNIT, MODEL HCU 30Jostra AB · 2003-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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