FDA-Device2014-06-11Class II
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Cincinnati Sub-Zero Products Inc
Hazard
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
Sold states
The product was distributed to one customer in MI, and internationally (Taiwan)
Affected count
7 units
Manufactured in
12011 Mosteller Rd, Cincinnati, OH, United States
Products
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2014Don't want to check this manually?
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