FDA-Device2021-07-21Class II

PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

C-RAD POSITIONING AB
Hazard

PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

Sold states
US Nationwide distribution in the states of IL, KY, MO and WA.
Affected count
7
Manufactured in
Bredgrand 18, Uppsala, Sweden
Products
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2075-2021

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