FDA Device recall Z-0419-2020
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compress…
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compress… by Cincinnati Sub Zero Products A Gentherm, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0419-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-02 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cincinnati Sub Zero Products A Gentherm |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Serial Numbers: 073-CB-00001 through 162-CB-00294 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0419-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.