Z-0350-2007

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

Name: Z-0350-2007 Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Creator: MAQUET Inc.
Published: 2006-11-10
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2006-11-10 / Terminated

FDA source

MAQUET Inc. began a recall of Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine on 2006-11-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0350-2007
Status: Terminated
Initiated: 2006-11-10
Posted: 2007-01-25
Terminated: 2007-02-05
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
FDA root cause: Other
Action: Letters were mailed to customers on 11/10/2006 by Federal Express.
Quantity in commerce: 13 units
Distribution: Hospitals in CA, NC, FL, WY, NY and WV.S
Product codes and lots: Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.

Product code DWC

K031544Class IIHeater Cooler Unit, Model Hcu 30Jostra AB / cleared 2003-08-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)