Siemens Medical Solutions USA, Inc ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

Recommended Action

Per FDA guidance

Siemens issued a Urgent Medical Device Correction Letter on 5/27/21 via AX064/20/S. Additionally, a software solution is being distributed via Update Instruction AX063/20/S to all affected customers. Letter states reason for recall, health risk and action to take: Planned procedures may have to be terminated and performed on an alternative X-ray system. 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 update the affected software to prevent this non-conformity from reoccurring via Update Instruction AX063/20/S. When the system recognizes a deviation of the intended travel path, unit movements will be stopped immediately, similar to an activation of a proximity switch. 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. Request that you promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner.