FDA recall Z-2075-2021

C-RAD POSITIONING AB · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of IL, KY, MO and WA.

Key facts

Status
Terminated
Initiation date
2020-08-06
Report date
2021-07-21
Termination date
2022-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Uppsala, Sweden

Primary source

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