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.

Recall number

Z-0821-2019

Recalling firm

Elekta, Inc.

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.

Status

Open, Classified

Initiated

2018-12-13

Posted

not on file

Terminated

not on file

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 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

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.

Lot, serial or model codes

MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher.   UDI 858164002084 858164002091 858164002107 858164002220 858164002237

510(k) numbers

["K120067","K123230","K141572","K981313"]

PMA numbers

not on file

Product code

IYE

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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