Device Recall HeaterCooler Device 의 리콜

Recall

75641

Class 2

Z-0654-2017

2016-11-07

2016-11-22

Terminated

United States

2017-02-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150976

The device may not maintain water flow or temperature control.

Cincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810