Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0419-2020 — CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

U.S. FDA — Device Enforcement · United States · 2019-07-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0419-2020
Date of alert: 2019-07-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0419-2020 — CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

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