Elekta, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3110-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

MOSAIQ Medical Charged-Particle Radiation Therapy System

Product Classification:

Class II

Date Initiated: June 30, 2017

Date Posted: September 13, 2017

Recall Number: Z-3110-2017

Event ID: 77758

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.

Status: Terminated

Product Quantity: 2,461

Code Information:

All software builds.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated