—#198098

Product

SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193178
Affected lot / code info: UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792

Why it was recalled

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Root cause (FDA determination)

Process control

Action the firm took

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"

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.

Timeline

Recall initiated: 2023-01-16
Posted by FDA: 2023-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198098. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.