FDA Device recall Z-0760-2016
Arctic Sun 5000 and Arctic Sun 2000
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Arctic Sun 5000 and Arctic Sun 2000 by C R Bard, citing improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient tempera….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0760-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-10 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | US |
Product
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Reason
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
Identifiers
| code_info | All lots/serial numbers sold prior to August 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0760-2016%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.