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U.S. Department of Health and Human Services

Class 2 Device Recall Magic View

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 Class 2 Device Recall Magic Viewsee related information
Date Initiated by FirmApril 01, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall NumberZ-1095-04
Recall Event ID 28823
510(K)NumberK935694 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductImage Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
Code Information All software associated with Image Navigator feature in Magic View
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactMr. Roland Richter
610-448-1777
Manufacturer Reason
for Recall		Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain CT or MR images.
FDA Determined
Cause 2		Other
ActionThe recalling firm has issued a letter to their Siemens Service Engineers to visit each affected sites, in order to correct the software problems. Additionally, a letter advising of the software problems was also sent to the Radiology Director at the affected sites, informing them of the 'Customer Safety Advisory' and the pending visit of the Seimens Service Engineers to perform a software update. Along with these letters, is a set of instructions detailing the potential risks and that a representative from the recalling firm will be contacting the medical facilities.
DistributionNationwide. The product was shipped to various medical facilities, in the following states, AK, GA, FL, IA, MA, MI, MO, NH, NJ, NY, NV, OK, PA, TX, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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