Z-0557-2016Class II

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for...

Name: Z-0557-2016 MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for...
Creator: Elekta, Inc.
Published: 2015-12-09
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-12-09 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports... on 2015-12-09. FDA classified it as Class II and gives the reason as "Incorrect drug dosage due to "Age Limit" and patient weight data item issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0557-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-09
Posted: 2015-12-29
Terminated: 2022-09-27
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System 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: Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 371-01-MSQ-005" to all customers on 12/9/2015. The notice informs users of the specific product and version numbers affected by both issues, also includes a workaround for both issues. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to return the acknowledgement form to their local Elekta as soon as possible-Fax: 408-830-8003. If you have any queries about this Notice, please contact your local Elekta office, call 408-830-8000 or toll free: 855-693-5358 or www.elekta.com.
Quantity in commerce: 399
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.
Product codes and lots: Versions 2.50 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-29

Product code IYE

K141572Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2014-09-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)