—#179548

Product

ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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 AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis 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: K163286
Affected lot / code info: All serial numbers

Why it was recalled

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued Urgent Medical Device Correction letter dated January 24, 2020 A via AX064/19/S ( corrective action via AX063/19/S), stating reason for recall, health risk and a corrective action: In the event the robotic stand shows stuttering movements or a squealing noise while initiating movements, do not move the robotic stand and C-arm any longer. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the hardware error by replacing all affected relays and altering the wiring via Update Instruction AX063/19/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-01-24
Terminated: 2020-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179548. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.