—#181349

Product

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193326
Affected lot / code info: Serial Numbers: 180014 180015 180018 180019 180029

Why it was recalled

Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued Urgent Medical Device Correction (AX035/20/S) dated 4/23/20. The letter states reason for recall health risk and action to take: We urgently recommend not to use Quantification Application (QVA/QCA) on DSA images until the software problem has been resolved. If Quantification Application has already been used on DSA images in the past, please verify the results and diagnostic evaluation if applicable. Siemens will correct the error with a software patch via Update Instruction AX034/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: AZ, IL, UT, WI

Timeline

Recall initiated: 2020-04-23
Terminated: 2020-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.