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C-RAD POSITIONING AB recalls PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Recalled July 21, 2021 · FDA recall Z-2075-2021 · C-RAD POSITIONING AB
Hazard
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step · FDA Class II
Units
7
Sold at
US Nationwide distribution in the states of IL, KY, MO and WA.
Description
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Manufacturer(s)
C-RAD POSITIONING AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →