Class 2 Device Recall Luminos dRF Max

• Date Initiated by Firm: July 02, 2024
• Date Posted: August 07, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2526-2024
• Recall Event ID: 94948
• 510(K)Number: K173639
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
• Code Information: UDI: Serial Numbers: Serial Number 8320 8198 8334 8474 8183 8322 8613 8244 8660 8436 8095 8371 8378 7805 5664 5615 8150 8130 8300 8093 8468 7791 8479 7136
• FEI Number: 2240869
• 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: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens issued Customer Safety Advisory Notice (CSAN) XP017/24/S to Director of Diagnostic Imaging and/ or Radiology Laboratory on 7/2/24. Letter states reason for recall, health risk and action to take: Please visually inspect the mounting screw on the ceiling tube (Figure 1) or wall tube (Figure 2) of the display suspension as far as this is possible from the floor. In case the visual inspection of the mounting screw does not show any abnormalities, you can continue to use the system. Nevertheless, until the system has been checked by Siemens Healthineers customer service with the planned field action, we recommend: - not to swivel the support arm of the display ceiling/wall suspension to the mechanical limit with great force and - to ensure that there is no one under the display ceiling/wall suspension when positioning the displays. This Customer Safety Advisory Notice (XP017/24/S) is being distributed to all potentially affected customers. Siemens Healthineers is preparing a field safety corrective action that will be provided with Update XP018/24/S starting in the third quarter of 2024. The corrective action will involve check and replacement of the attachment of the support arm for the display ceiling/wall suspension by a service technician in an onsite visit. In instances where the mounting screw is broken, the support arm will also be replaced with update XP019/24/S. These field actions will be provided to you free of charge. Once the corrective actions are available, our customer service team will contact you to schedule an appointment to perform the above safety corrective action(s). Once the updates are available and if you would like to make an earlier appointment, please feel free to contact customer service at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification
• Quantity in Commerce: 24 units
• 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