Blanketrol II Hyper-Hypothermia Temperature Managment System

• • Ongoing Z-2968-2026 FDA Class II ·initiated 13 Jul 2026

  Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.

• • Terminated Z-0418-2020 FDA Class II ·initiated 2 Jul 2019

  Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

• • Terminated Z-1679-2014 FDA Class II ·initiated 8 Jan 2014

  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

510(k) Number

K110104 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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