Recall Z-0350-2007 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
MAQUET Inc.
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
| Date | Jan 25, 2007 (initiated Nov 10, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 Jostra AB, Aug 7, 2003 |