Z-3110-2017Class II

MOSAIQ Medical Charged-Particle Radiation Therapy System

Name: Z-3110-2017 MOSAIQ Medical Charged-Particle Radiation Therapy System
Creator: Elekta, Inc.
Published: 2017-06-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-06-30 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Medical Charged-Particle Radiation Therapy System on 2017-06-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3110-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Posted: 2017-09-06
Terminated: 2020-10-26
Recalling firm: Elekta Limited
Product: MOSAIQ Medical Charged-Particle Radiation Therapy System
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
Root cause tag: software
FDA root 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
Product codes and lots: All software builds.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3110-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3110-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-06

Product code LHN

K141572Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2014-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)