Class 2 Device Recall Siemens Artis zeego

• Date Initiated by Firm: September 24, 2021
• Create Date: November 04, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0200-2022
• Recall Event ID: 88820
• 510(K)Number: K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis zeego, Fluoroscopic X-Ray System; Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models:; Product/Model #:; syngo X Workplace, 10281061; syngo X Workplace, 10281299; syngo X Workplace, 10502522; Syngo Application Software, 10848815
• Code Information: Artis zeego systems with Artis patient table and AppSW VD20C/VD20N
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
• FDA Determined Cause: Software design
• Action: Siemens Healthineers issued Urgent Medical Device Correction Letter (AX059/21/S) dated 9/24/21. Letter states reason for recall, health risk and action to take: To avoid possible incorrect patient treatment, Siemens recommends a working position with 0 degree table rotation be used if intraoperative 3D images are required for subsequent steps (e.g., image superimposition, C-arm positioning, laser cross). If it should still be necessary to use a table rotation other than 0 degrees for intraoperative 3D images, please verify the C-arm position, needle position and image superimposition, by means of fluoroscopy. Siemens will provide a software update for all affected systems in which the system calculates table rotations and 3D reconstructions correctly. This corrective action will be distributed via Update Instruction AX058/21/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. 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.
• Quantity in Commerce: 43 US
• Distribution: US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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