Siemens Medical Solutions USA, Inc Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 102809 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Recommended Action

Per FDA guidance

Siemens iMedical Solutions USA Inc. issued A Customer Safety Advisory Notice dated 8/03/20 affected customers via AX047/20/S. Letter states reason for recall, health risk and action to take:Siemens strongly recommends paying close attention during system movements to avoid any collision and to establish appropriate emergency procedures until the corrective action has been performed. In case of collision, it is recommended to check the system for any damages before continuing with treatment. If any device part continues to move although that movement was not released, a potential malfunction may be present. In this case, the system must be shut down and Siemens Healthineers service organization must be informed. Our service organization will contact you to schedule an appointment to perform inspection of the affected system by Siemens service engineer, and, where necessary, recover the individual room configuration data setings This correction will be implemented via Update Instruction AX046/20/S. Following the inspection by a service engineer the individual room configuration data settings will be available again. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.