FDA-Device2023-02-22Class II
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Hazard
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Sold states
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Affected count
1 unit
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2023Don't want to check this manually?
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