FDA Device

SICAT IMPLANT V2.0

Hazard

A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

What You Should Do

Remedy

On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.

Products

SICAT IMPLANT V2.0
Brand
SICAT GMBH & CO. KG Brunnenallee
UPC
V2.0

Units Affected

853 units