Recall Z-3110-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Elekta, Inc.
MOSAIQ Medical Charged-Particle Radiation Therapy System
| Date | Jun 30, 2017 |
| Status | Terminated |
| Reason | 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 | 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 acknowl |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |