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U.S. Department of Health and Human Services

Class 2 Device Recall Simview NT with IDI

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  Class 2 Device Recall Simview NT with IDI see related information
Date Initiated by Firm February 27, 2007
Date Posted January 31, 2008
Recall Status1 Terminated 3 on February 03, 2011
Recall Number Z-0284-2008
Recall Event ID 45495
510(K)Number K946053  
Product Classification Stimulation Radiation Therapy System - Product Code KPQ
Product Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520
Code Information Serial Numbers: 6018, 6001, 6008, 6067, 6037, 6038, 6059, 6041, 6047, 6017, 6027, 6036, 6040, 6050, 1256, 6082, 6056, 6064, 6083, 6034, 6044, 6055, 6058, 6028, 6090, 6105, 2255, 6079, 6089, 6073, 6052, 6077, 6072, and 6066.
Recalling Firm/
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
Manufacturer Reason
for Recall
Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
FDA Determined
Cause 2
Labeling design
Action Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.
Quantity in Commerce 287 units total, all recalls Z-0281-285-2008
Distribution Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countries of Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, China, Israel/Palestine, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, UK, and Vietnam.
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.