25

Sep

2023

FDA Recall: Software Library Filtering Error Could Lead to Patient Injury

0

Company: Exocad GmbH
Date of Enforcement Report:9/25/2023
Class II

PRODUCT

exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.

Recall Number:

Z-2633-2023

REASON:

A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury

RECALLING FIRM/MANUFACTURER:

Exocad GmbH

VOLUME OF PRODUCT IN COMMERCE:

96 licenses

DISTRIBUTION:

Worldwide distribution – US Nationwide and the country of Canada.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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