Recall Z-2075-2021— C-RAD POSITIONING AB

Name: FDA recall Z-2075-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-06

Class II · Terminated

Class II FDA medical device recall by C-RAD POSITIONING AB, initiated 2020-08-06, terminated 2022-04-15. It names one FDA 510(k) clearance: K113276. 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: PC Application Software c4D not changing Site upon synchronization during the Setup workflow step.

Recalling firm: C-RAD POSITIONING AB
Classification: Class II
Status: Terminated
Initiated: 2020-08-06
Terminated: 2022-04-15
Firm location: Uppsala, Sweden

510(k) clearances named in this recall

1 on FDA's record

K113276 — CATALYSTC-Rad Positioning AB·cleared 2012-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.