| Class 2 Device Recall Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KPQ
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