Z-0821-2019Class II

MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage...

Name: Z-0821-2019 MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage...
Creator: Elekta, Inc.
Published: 2018-12-13
License: https://open.fda.gov/license/

Elekta Limited / initiated 2018-12-13 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It... on 2018-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0821-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-12-13
Posted: 2019-02-08
Recalling firm: Elekta Limited
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0821-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0821-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-08

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)