—#151943

Product

Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123529
Affected lot / code info: Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355

Why it was recalled

Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702. For questions regarding this recall call 610-448-6461.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-12-08
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.