FDA-Device2023-02-22Class II
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
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
6 units
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2023Don't want to check this manually?
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