Class 2 Device Recall MOSAIQ Oncology Information System and Sequencer

• Date Initiated by Firm: December 13, 2018
• Create Date: February 08, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0821-2019
• Recall Event ID: 81785
• 510(K)Number: K120067 K123230 K141572 K981313
• Product Classification: Accelerator, linear, medical - Product Code IYE
• 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.
• Code Information: MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter NE Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Alejandra Carrillo ; 404-202-4333
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYE