FDA Device recall Z-2536-2018
Arctic Sun Temperature Management System, Model 5000
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Arctic Sun Temperature Management System, Model 5000 by Bard Medical Division, citing an improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2536-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-13 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Medical Division |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.
Reason
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Identifiers
| code_info | Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03,…Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08. All serial numbers are affected. |
|---|
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-2536-2018%22
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