FDAFDA · Food and drugs·Recall number Z-0997-2013
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Published April 3, 2013 · Recall initiated: March 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- 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.
- Lot
- Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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