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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Biograph mCT, Biograph Horizon, Biograph Vision see related information
Date Initiated by Firm January 16, 2023
Date Posted February 13, 2023
Recall Status1 Open3, Classified
Recall Number Z-1134-2023
Recall Event ID 91518
510(K)Number K193178  
Product Classification System, tomography, computed, emission - Product Code KPS
Product SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Code Information UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792
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 2		 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 1 unit
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 and Original Applicant = Siemens Medical Solution USA, Inc.
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