Reason: Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
Distributed: Worldwide - U.S. Nationwide distribution in the states of AL, CA, PA, SC, GA, MA, TX, OH, NY, NC, IA, WA, TN, NJ, MO, LA, MN, AZ, VA, SC, KY, FL, MD, IN, AK, WI, NM, DC, RI, CT, CO, OK, DE, NE, MD, IL, NH and the countries of Germany, Canada.Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distributed: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distributed: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distributed: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distributed: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distributed: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.Reason: Software anomaly in the patient positioning system may result in positional discrepancy.
Distributed: US distribution to states of: TX, Washington DCReason: Software anomaly in the patient positioning system may result in positional discrepancy.
Distributed: US distribution to states of: TX, Washington DCReason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Distributed: US distribution: LA, MA, NY, PA, TX, and VA.Reason: Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
Distributed: Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.