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U.S. Department of Health and Human Services

Class 2 Device Recall ELEKTA MOSAIQ SW

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  Class 2 Device Recall ELEKTA MOSAIQ SW see related information
Date Initiated by Firm December 20, 2012
Date Posted April 10, 2013
Recall Status1 Terminated 3 on July 19, 2013
Recall Number Z-1077-2013
Recall Event ID 63974
510(K)Number K123230  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
757 Arnold Dr Ste A
Martinez CA 94553-3615
For Additional Information Contact Ghada Trotabas
925-602-8157
Manufacturer Reason
for Recall		 A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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