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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Systems with Software Artis VC20x/VC21A/VD10x

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 Class 2 Recall
Artis Systems with Software Artis VC20x/VC21A/VD10x
see related information
Date Posted March 26, 2013
Recall Status1 Terminated on November 06, 2014
Recall Number Z-0997-2013
Recall Event ID 64662
Premarket Notification
510(K) Numbers
K073290  K090745 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Code Information Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Siemens sent a Customer Safety Advisory Notice on March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information on to all those who need to be aware of it and to instruct their personnel accordingly. Customers were asked to forward the safety information to other organizations that couald be affected by this action. For questions regarding this recall call 610-219-6300.
Quantity in Commerce 81
Distribution Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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