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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems

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  Class 2 Device Recall Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems see related information
Date Initiated by Firm March 10, 2008
Date Posted June 28, 2008
Recall Status1 Terminated 3 on December 22, 2010
Recall Number Z-2196-2008
Recall Event ID 48655
510(K)Number K946053  K953233  
Product Classification System, Simulation, Radiation Therapy - Product Code KPQ
Product Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems;
Part Number: 5488460; Product is manufactured and distributed by
Siemens Medical Solutions, Oncology Care System,
4040 Nelson Ave, Concord CA

The product is indicated for use in Radiation therapy simulation.
Code Information All codes.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Dan Takemoto
925-246-8407
Manufacturer Reason
for Recall		 The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
FDA Determined
Cause 2		 Software design
Action On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.
Quantity in Commerce 300 units
Distribution Worldwide and Nationwide
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 = KPQ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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