Z-1597-2020Class II

MOSAIQ, oncology information system -

Name: Z-1597-2020 MOSAIQ, oncology information system -
Creator: Elekta Impac Software
Published: 2019-09-24
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-09-24 / Open, Classified / root cause: software

FDA source

Elekta Impac Software began a recall of MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery on 2019-09-24. FDA classified it as Class II and gives the reason as "The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units". 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-1597-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-24
Posted: 2020-03-26
Recalling firm: Elekta Limited
Product: MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Root cause tag: software
FDA root cause: Software design
Action: The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release.
Quantity in commerce: 3732 units
Distribution: Worldwide distribution.
Product codes and lots: Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1597-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1597-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code MUJ

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)