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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 Posting Updated 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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