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Elekta, Inc. recalls MOSAIQ Medical Charged-Particle Radiation Therapy System
Recalled September 13, 2017 · FDA recall Z-3110-2017 · Elekta
Hazard
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 Class II
Units
2,461
Sold at
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
Description
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.
Product
MOSAIQ Medical Charged-Particle Radiation Therapy System
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →