Z-2917-2018Class II

MOSAIQ Oncology Information System

Name: Z-2917-2018 MOSAIQ Oncology Information System
Creator: Elekta, Inc.
Published: 2018-08-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2018-08-03 / Terminated

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System on 2018-08-03. FDA classified it as Class II and gives the reason as "Order Status Remains Approved When Should Indicate Complete". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2917-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Posted: 2018-08-23
Terminated: 2024-09-23
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Order Status Remains Approved When Should Indicate Complete.
FDA root cause: Unknown/Undetermined by firm
Action: On August 2018 the firm sent letter to all their customer with the following instructions; Recommended User Action: A user with appropriate pharmacy rights can unlock the record. This blanks out the details requiring the user to re-enter the administration details previously entered. To avoid this locking issue, close the MAR window before navigating to the CWS. This document contains important information for the continued safe and proper use of your equipment. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. Advise the appropriate personnel working with this product the content of this letter. Elekta Corrective Actions: The issue is resolved in MOSAIQ Release 2.65 Beta 02 and in release 2.64 SP10. In order to meet regulatory requirements, you are required to complete this the Acknowledgement Form and return it to Elekta immediately upon receipt but no later than 30 days.
Quantity in commerce: 185
Distribution: AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom
Product codes and lots: Software Build(s) 2.64 SP3 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2917-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2917-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-23

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