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Recall Observatory FDA recall evidence

Device product

Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

Z-3042-2017

March 31, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    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.