Recall – Dental implant planning software incorrectly exports implant positions

Company: SICAT GMBH & CO. KG
Date of Enforcement Report: 9/16/2020
Class II

PRODUCT

SICAT IMPLANT V2.0

Recall Number: Z-2951-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

SICAT GMBH & CO. KG on 7/15/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

853 units

DISTRIBUTION

U.S. Nationwide and International

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.