Bard Medical Division: 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 32C to 38.5C (89.6F to 101.3F) in adult and pediatric patients of all ages.

Recall number

Z-2536-2018

Recalling firm

Bard Medical Division

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 32C to 38.5C (89.6F to 101.3F) in adult and pediatric patients of all ages.

Status

Terminated

Initiated

2018-06-13

Posted

not on file

Terminated

2021-02-16

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.

Root cause

Process control

Action

The firm,Bard Medical, sent a "MEDICAL DEVICE CORRECTION" letter dated 6/13/2018 to its customers. Bard Medical advised their customers to examine inventory and identify any ARCTIC SUN 5000 Temperature Management Systems that match the attached Serial Number List they sent with the letter. The firm also asked their customers to complete the online acknowledgement form(link was provided in the letter) if a customer had an ARCTIC SUN 5000 Temperature Management Systems that matches the serial number list. If a customer had further distributed or transferred an ARCTIC SUN 5000 Temperature Management System, Bard Medical advised the customer to please identify the respective organizations and notify them at once of this communication, including a copy of this communication letter and accompanying attachments and to have the organization promptly complete the online acknowledgement form in the link provided. Upon completion of the online acknowledgement form, the customer will be contacted by a customer service representative to schedule the unit(s) for repair. The link to the Online Acknowledgement Form: www.novasyte.com/as5000 Bard Medical stated they partnered with Novasyte to assist in this action. Novasyte contact information is as follows: Phone: (760) 507-1908 Email: AS5000@novasyte.com

Quantity

5608 Units Total

Distribution

Domestic 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. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.

Lot, serial or model codes

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.

510(k) numbers

["K161602"]

PMA numbers

not on file

Product code

DWJ

Firm FEI

1018233

Firm city

Covington

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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