—#115155

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123230
Affected lot / code info: 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.

Why it was recalled

A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 757 Arnold Dr, Ste A, Martinez, California 94553-3615

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2012-12-20
Posted by FDA: 2013-04-10
Terminated: 2013-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115155. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.