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U.S. Department of Health and Human Services

Class 2 Device Recall PRIMEVIEW 3i System 2.0

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  Class 2 Device Recall PRIMEVIEW 3i System 2.0 see related information
Date Initiated by Firm November 06, 2007
Date Posted October 16, 2008
Recall Status1 Terminated 3 on December 18, 2010
Recall Number Z-0097-2009
Recall Event ID 48432
510(K)Number K060226  
Product PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847

Medical charged-particle radiation therapy system.
Code Information Serial numbers associated with RTT2.0 and RTT2.1
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall
Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
FDA Determined
Cause 2
Software design
Action Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.
Quantity in Commerce 50 units
Distribution Worldwide Distribution

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 = and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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