PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 21, 2021 Initiated: August 6, 2020 #Z-2075-2021

Product Description

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

Details

Recalling Firm
C-RAD POSITIONING AB
Units Affected
7
Distribution
US Nationwide distribution in the states of IL, KY, MO and WA.
Location
Uppsala

Frequently Asked Questions

What product was recalled?
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0. Recalled by C-RAD POSITIONING AB. Units affected: 7.
Why was this product recalled?
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Which agency issued this recall?
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2075-2021.