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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 Recall
Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems
see related information
Date Posted June 28, 2008
Recall Status1 Open
Recall Number Z-2196-2008
Recall Event ID 48655
Premarket Notification
510(K) Numbers
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, California 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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