MOSAIQ recallZ-0821-2019 · Elekta, Inc. · initiated Dec 13, 2018
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software change control
What the company is doing
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.
Recall details
- Recall number
- Z-0821-2019
- Status
- Open, Classified
- Initiated by the company
- Dec 13, 2018
- Recalling firm
- Elekta, Inc.
- Quantity
- 3,950 units total (1,747 US)
- Product code
- IYE
- FDA submissions
- K120067, K123230, K141572, K981313
- 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.
Product description
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 (models, lots, serial numbers)
MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page