Recall Z-0821-2019 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
| Date | Dec 13, 2018 |
| Status | Open, Classified |
| Reason | There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates. |
| Root cause | Software change control |
| Action | Elekta sent a letter to affected customers titled, Urgent Field Safety Notification, on about 12/13/2018. The letter contained recommended user action to review the TPS system to verify that Wedge IDs are defined for all wedges and check to make sure that the exported RT Plan information contains the necessary Wedge IDs. Instructions also included to post the recall notice in a place accessible to all users until the correction is closed, and to advise the appropriate personnel working with the affected product of the recall. The letter stated that the issue will be resolved in MOSAIQ Rel |
| Quantity | 3,950 units total (1,747 US) |
| Distribution | U.S. Nationwide distribution to the following states AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the District of Columbia and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Feb 28, 2012 |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Dec 12, 2012 |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |