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Terminated

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 Recall Z-2367-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-07-30
Date Terminated2020-04-29
Product QuantityUS 17

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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