—#116731

Product

Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290, K090745
Affected lot / code info: Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-03-08
Posted by FDA: 2013-03-26
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116731. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.