—#144567

Product

Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133580
Affected lot / code info: Serial # 82010, material # 10848600

Why it was recalled

After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

Siemens mailed an Important Customer Safety Notice to customers to inform them of the issue and the corrective actions they plan to take to address the problem. The letter stated that Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers were instructed to call Siemens service organization for an appointment at 1-800-888-7436.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide Distribution to Michigan only

Timeline

Recall initiated: 2016-03-11
Terminated: 2017-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144567. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.