Z-0686-2019Class II

MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage...

Name: Z-0686-2019 MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage...
Creator: Elekta, Inc.
Published: 2018-12-04
License: https://open.fda.gov/license/

Elekta Limited / initiated 2018-12-04 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery on 2018-12-04. FDA classified it as Class II and gives the reason as "If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter...". 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-0686-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Posted: 2018-12-27
Terminated: 2026-02-23
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
Root cause tag: software
FDA root cause: Software design
Action: Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification." The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin. An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358.
Quantity in commerce: 551 units
Distribution: Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam
Product codes and lots: Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0686-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0686-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-27

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)