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Terminated

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

FDA Recall Z-2075-2021 · Posted None

Recalling FirmC-RAD POSITIONING AB
Recall StatusTerminated
Product CodeIYE
Date Initiated2020-08-06
Date Terminated2022-04-15
Product Quantity7

Reason for Recall

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

Firm Action

On August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state..

Root Cause

Component change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113276CATALYSTC-Rad Positioning AB · 2012-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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