Z-1077-2013Class II

ELEKTA MOSAIQ SW version below 2.41

Name: Z-1077-2013 ELEKTA MOSAIQ SW version below 2.41
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-12-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-12-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver... on 2012-12-20. FDA classified it as Class II and gives the reason as "A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc". 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-1077-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-04-10
Terminated: 2013-07-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Medical Device Correction letter with update instructions to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your responsible Siemens Service Engineer or Application Specialist.
Quantity in commerce: 101
Distribution: Worldwide Distribution
Product codes and lots: System No. 10568605:100044 100078 100085 100088 100098 100135 100020 100025 100001 100002 100003 100004 100006 100007 100008 100009 100010 100011 100012 100013 100014 100016 100017 100019 100023 100024 100028 100029 100030 100031 100032 100033 100034 100035 100036 100037 100038 100039 100040 100041 100042 100045 100047 100049 100051 100052 100053 100054 100056 100058 100059 100060 100061 100062 100063 100065 100066 100068 100069 100070 100071 100072 100073 100074 100075 100077 100079 100080 100082 100086 100087 100089 100090 100091 100092 100093 100094 100099 100101 100103 100104 100106 100107 100108 100111 100112 100113 100114 100115 100118 100119 100120 100121 100123 100124 100125 100126 100127 100130 100131 100133 100136 100138 100140.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-09

Product code IYE

K123230Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2012-12-12

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)