Z-0731-2017Class II

MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and...

Name: Z-0731-2017 MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and...
Creator: Elekta, Inc.
Published: 2016-12-02
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-12-02 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare... on 2016-12-02. FDA classified it as Class II and gives the reason as "Edits to Particle field definition parameters may not be saved when the field definition window is saved". 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-0731-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2016-12-09
Terminated: 2021-11-05
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Edits to Particle field definition parameters may not be saved when the field definition window is saved.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter dated 11/2016 was sent to affected customers on 12/2/2016. The letter describes the product, problem and actions to be taken. The customers were instructed to save and re-open the field definition form when manual edits have been performed to confirm that the edits were save; post this notice in a place accessible to all users; advise the appropriate personnel working with the product the content of the letter; and complete and return the Acknowledgement Form via fax to: 408 830 8003 immediately upon receipt but no later than 30 days. Elekta will resolve the problem with the MOSAIQ 2.60 SP7F, MOSAIQ 2.60 SP14 and 2.64 SP3. Customers are encouraged to contact Elekta support to get the corrected version. If you have any questions, contact RA Manager Americas at 1-770-300-9725 or email to: [email protected].
Quantity in commerce: 47
Distribution: Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden and United Kingdom.
Product codes and lots: Versions 2.60 an higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-09

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)