Device product
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Z-3042-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 77794
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,450 units
- Official record key
device-enforcement:Z-3042-2017
Official wording
Reason: Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
Code information: Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
Derived failure modes
-
Unknown
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.