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.
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling its MOSAIQ Oncology Information System and Sequencer due to a potential issue where Wedge IDs may not be included in treatment plans sent from the treatment planning system. When Wedge IDs are missing, the MOSAIQ system creates treatment fields without the planned wedge, which can result in patients receiving higher radiation doses than indicated in their approved treatment plans. The affected software includes MOSAIQ Radiation Oncology version 1.0 and higher, and Multi-ACCESS version 6.1 and higher. A total of 3,950 units have been distributed nationwide across all U.S. states, the District of Columbia, and Puerto Rico.
The recall notice does not specify a remedy or corrective action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 3,950 units total (1,747 US) Lot/code info: MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.