Z-0447-2016Class II

MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery

Name: Z-0447-2016 MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery
Creator: Elekta, Inc.
Published: 2015-11-24
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-11-24 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery on 2015-11-24. FDA classified it as Class II and gives the reason as "First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included...". 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-0447-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-24
Posted: 2015-12-17
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt.
Quantity in commerce: 211
Distribution: Nationwide Distribution -- AL, 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, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.
Product codes and lots: Versions prior to 2.60.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0447-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0447-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-17

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)