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U.S. Department of Health and Human Services

Class 2 Device Recall Jostra Heater Cooler

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 Class 2 Recall
Jostra Heater Cooler
see related information
Date Posted January 25, 2007
Recall Status1 Terminated on February 05, 2007
Recall Number Z-0350-2007
Recall Event ID 37023
Premarket Notification
510(K) Number
K031544 
Product Classification Controller, Temperature, Cardiopulmonary Bypass - Product Code DWC
Product Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Code Information Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
Recalling Firm/
Manufacturer
MAQUET Inc.
1140 US Highway 22
Bridgewater, New Jersey 08807-2958
For Additional Information Contact Jamie Yieh
908-947-2311
Manufacturer 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 Determined
Cause 2
DESIGN: Software Design
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWC and Original Applicant = JOSTRA AB
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