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.
Enforcement
- Recall Number
- Z-2633-2023
- Event ID
- 92921
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Exocad GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 4, 2023
- Initiation Date
- August 17, 2023
- Classification Date
- September 25, 2023
- Address
- Julius-Reiber-Str. 37, N/A, Darmstadt, N/A, N/A, Germany
Description
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.
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
UDI-DI: (01)4260521365026(10)A03B01E8439 (US) (01)4260521365026(10)A03B01E8588 (SR1 US) (01)4260521365026(10)A03B01E8606 (SR1 US offline) Software xoplan 3.1 Rijeka
Worldwide distribution - US Nationwide and the country of Canada.
96 licenses