Class 2 Device Recall Artis zee floor

• Date Initiated by Firm: November 14, 2019
• Create Date: December 17, 2019
• Recall Status: Terminated on May 12, 2020
• Recall Number: Z-0695-2020
• Recall Event ID: 84370
• 510(K)Number: K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
• Code Information: Model Number: 10094142 Serial Number: 140422, 140423, 140430 Software Version: VC21C
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Meredith Adams; 610-219-4834
• Manufacturer Reason for Recall: In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.
• FDA Determined Cause: Software design
• Action: On November 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE CORRECTION Dear Customer, This letter is to inform you of a corrective action that will be performed to prevent a possible hazard to patients, operators, or other persons and equipment due to a potential software error in software version VC21C and serial numbers 140422, 140423 or 140430. Artis zee systems with software version VC21C and serial # 140422, 140423 or 140430 This potential software issue has no influence on the previous treatment/diagnosis of patients. However, in case of software failure, planned procedures may have to be terminated and perfomed on an alternative x-ray system. What is the underlying issue requiring corrective action and when does the issue occur? In affected Artis systems, the movement of the floating tabletop may become blocked after a collision sensor has been activated during system movements. The collision supervision will display a user message on the monitor. What is the impact on system operation and what are the potential risks? During normal operation, activation of a collision sensor will cause a block of any system movements but moving the floating tabletop is still possible. In affected Artis systems, the movement of the floating tabletop is blocked and could result in a delay or interruption of a procedure. We do not consider it necessary to re-examine any patients in this case as this possible software error had no influence on treatment of patients. How was the issue detected, what is the cause, and what action will be taken? The issue was detected during regular field monitoring. The root cause for the blocked tabletop movement (horizontally and vertically) is a software error of the stand control unit. By using the safety override function and moving out of the collision zone, the system movement can be resumed. In safety override mode you may try to resolve a coll
• Quantity in Commerce: 3
• Distribution: US: WA and TX International: Denmark
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solution USA, Inc.