SICAT IMPLANT V2.0 Software Recall Due to Incorrect Implant Position Export
SICAT GMBH & CO. KG is recalling SICAT IMPLANT V2.0 software because implant positions may not export correctly in the CMG.DXD format.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect clinical data (implant positions), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
SICAT GMBH & CO. KG is recalling 853 units of SICAT IMPLANT V2.0 software. The recall was initiated after a dentist discovered that implant positions are not correctly exported from the software when using the specific CMG.DXD export format.
The affected software was distributed worldwide. The issue involves a data export error that could result in incorrect implant positioning data being transferred to other systems.
Consumers and healthcare professionals using this software should stop using the CMG.DXD export format and contact the manufacturer for further instructions on how to resolve the issue.
The recalled product
- Product
- SICAT IMPLANT V2.0
- Manufacturer
- SICAT GMBH & CO. KG
- Category
- Medical Device — Dental Software
- Affected units
- 853
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- V2.0
Distribution
Distribution scope not specified by the agency.
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