U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
System, thermal regulating - Product Code DWJ
원인
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and static random access memory (sram). this premature coin cell battery drainage could render the device unresponsive upon system startup.
조치
BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation.
Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com.
For questions regarding this recall call 770-784-6220.
Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom
제품 설명
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V || The product is a thermal regulating system indicated for monitoring and controlling patient temperature