Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

Siemens issued Urgent Medical Device Correction letter dated March 26, 2021. Letter states reason for recall, health risk and action to take: Siemens will inspect the potentially affected area and will install an additional cover to improve the cable guidance and prevent further cable harness damage via Update Instruction AX008/20/S. If damage caused by abrasion is too severe, the cable harness will be replaced via Update Instruction AX011/20/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. 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.