FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
- Recall number
- Z-0350-2007
- Recalling firm
- MAQUET Inc.
- Product
- Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
- Status
- Terminated
- Initiated
- 2006-11-10
- Posted
- 2007-01-25
- Terminated
- 2007-02-05
- Reason
- 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.
- Root cause
- Other
- Action
- Letters were mailed to customers on 11/10/2006 by Federal Express.
- Quantity
- 13 units
- Distribution
- Hospitals in CA, NC, FL, WY, NY and WV.S
- Lot, serial or model codes
- Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
- 510(k) numbers
- ["K031544"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 3008355164
- Firm city
- Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28