MAQUET Inc. Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
Brand
MAQUET Inc.
Lot Codes / Batch Numbers
Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
Products Sold
Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
MAQUET Inc. is recalling Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Letters were mailed to customers on 11/10/2006 by Federal Express.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, NY, NC, WV, WY
Page updated: Jan 10, 2026