Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
FDA device recall Z-0350-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- 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.
- Action taken
- Letters were mailed to customers on 11/10/2006 by Federal Express.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWC
- Quantity affected
- 13 units
- Distribution
- Hospitals in CA, NC, FL, WY, NY and WV.S
- Date initiated
- 2006-11-10
- Date posted
- 2007-01-25
- Date terminated
- 2007-02-05
- Location
- Bridgewater, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEATER COOLER UNIT, MODEL HCU 30 (K031544) | Jostra AB | 2003-08-07 |