Class 2 Device Recall Biograph mCT, Biograph Horizon, Biograph Vision

• Date Initiated by Firm: January 16, 2023
• Date Posted: February 13, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1136-2023
• Recall Event ID: 91518
• 510(K)Number: K193248
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
• Code Information: a) 450: UDI/DI 405686923807410106, Material Number 10749669, Serial Number 10106; b) 600: UDI/DI 405686922450311120, Material Number 10749670, Serial Number 11120; UDI/DI 405686922450311116, Material Number 10749670, Serial Number 11116; c) 600 Edge: UDI/DI 405686918321311068, Material Number 10749672, Serial Number 11068
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60192-2061
• For Additional Information Contact: Siemens Healthineers Representative; 800-888-7436
• Manufacturer Reason for Recall: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
• FDA Determined Cause: Process control
• Action: SIEMENS Healthineers distributed a Consumer Safety Advisory Notice to its consignees on 01/16/2023 by mail and email. The notice explained the issue and recommended that the following preventive actions be taken until a local Siemens Healthineers service representative has applied the correction: "Mitigation for Biograph Mobile Installations Ensure that the PET/CT Gantry offset protocol is performed every time the coach has moved. If the PET/CT gantry offset fails due to the results being out of tolerance, please cease clinical operations on the system and contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Information on how to acquire the PET/CT Gantry offset protocol is documented in your user documentation. Mitigation for Biograph Seismic Installations In the event of a seismic event, contact your local Siemens Healthineers service representative for further evaluation and guidance on how to proceed. Siemens Healthineers will begin dispatching customer service engineers by the end of February 2023 to inspect and make corrections to the locking mechanism to prevent the occurrence of this issue. The resolution for this issue will be delivered by the following Update Instruction: MI516/22/S. Please ensure that this notice is placed in the Biograph Operator Manual and disseminated to all operators of the scanner." "If you have any questions regarding this advisory notice, please contact your local Siemens Healthineers representative at the contact numbers provided below. America: 1-800-888-7436 Europe, Middle East, and Africa: +49 9131 940 4000 Asia and Australia: +86 (21) 3811 2121"
• Quantity in Commerce: 4 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
• 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 = KPS