—#169845

Product

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K120067, K123230, K141572, K981313
Affected lot / code info: MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237

Why it was recalled

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 (FDA determination)

Software change control

Action the firm took

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 Release 2.80 Beta 01. The update will be provided in Service Packs to MOSAIQ and Multi-ACCESS who will be notified with a Product Bulletin when the Service Packs are available. An Acknowledgement Form was sent with the letter that should be completed and returned to Elekta within 30 days. The firm can be contacted at 408-830- 8000 or 855-693-5358.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.