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Siemens Medical Solutions USA, Inc. recalls 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
Recalled February 22, 2023 · FDA recall Z-1135-2023 · Siemens Medical Solutions USA
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. · FDA Class II
Units
6 units
Sold at
Worldwide distribution - US Nationwide and the countries of Japan, Chile, Australia.
Description
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Product
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
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →