—#175748

Product

Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego 10848283 ArtisQ.zen ceiling 10848354 Product Usage: Artis is 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. The Artis family 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: K181407
Affected lot / code info: Serial Numbers: 123245 103302 121501 148401 109589 148393 111129 148400 103310 148397 155235 121505 109563 121506 131235 121502 105125

Why it was recalled

Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts

Root cause (FDA determination)

Process control

Action the firm took

Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (AX011/19/S) on 8/1/19 a . The letter identifies the reason for recall, health risk and action to take: Siemens Service organization will inspect the table mainframe for possible cracks and will contact you shortly to arrange a date to perform this corrective action. Contact the 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 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI

Timeline

Recall initiated: 2019-07-30
Terminated: 2020-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.