Recall Z-2536-2018 ยท DWJ System, Thermal Regulating
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.
| Date | Jun 13, 2018 |
| Status | Terminated |
| 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 |
| 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, Brus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161602 | Arctic Sun Temperature Management System Medivance, Inc., Sep 2, 2016 |