Class 2 Device Recall MOSAIQ Oncology Information System

• Date Initiated by Firm: June 30, 2017
• Create Date: September 06, 2017
• Recall Status: Terminated on October 26, 2020
• Recall Number: Z-3110-2017
• Recall Event ID: 77758
• 510(K)Number: K141572
• Product Classification: System, radiation therapy, charged-particle, medical - Product Code LHN
• Product: MOSAIQ Medical Charged-Particle Radiation Therapy System
• Code Information: All software builds.
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter NE Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Elekta Care Support Center; 855-693-5358
• Manufacturer Reason for Recall: The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
• FDA Determined Cause: Software in the Use Environment
• Action: Consignees were to receive a recall notice by mail dated 06/30/2017. The notice identifies the reason for recall and goes on to instruct consignees to run verification tests on units to ensure they are operating properly. Only applicable tests should be performed on the unit. If the unit passes verification tests, then the attached acknowledgment form is to be signed and returned to Elekta. If the unit fails verification, consignees are instructed to contact their local Elekta Care Support Center for assistance. If a unit is no longer in use, consignees are asked to sign and return the acknowledgement form, noting that the unit is no longer in use. The firm asks that the recall notice be placed in an accessible area to users until the field action is closed. Appropriate personnel should also be provided the content of the recall notification.
• Quantity in Commerce: 2,461
• Distribution: Worldwide distribution. US nationwide to AK, AL, AR, AZ, CA, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BENIN, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, HONDURRAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, LAOS, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, VENEZUELA, VIETNAM and ZIMBABWE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LHN and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.