Siemens Medical Solutions USA, Inc. SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Siemens Medical Solutions USA, Inc. is recalling SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge due to This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Recommended Action
Per FDA guidance
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"
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026