CanadaInteleShare™ software (versions 3.24.3–3.25.2; model V3.24) from Intelerad Holdings USA Ltd. is affected. The length measurement tool may provide inconsistent or incorrect values when used in multi‑planar reconstruction with rotations applied, which could compromise diagnostic accuracy and potentially lead to patient harm such as misdiagnosis or inappropriate follow‑up. Contact the manufacturer for additional information.
What's being recalled
Companies: Intelerad Holdings Usa Ltd., 6th Floor, Raleigh, North Carolina, United States, 27609.
How to identify it
Affected products: InteleShare™; Lot or serial number: versions 3.24.3 - 3.25.2; Model or catalogue number: V3.24
The hazard
The length measurement tool may provide inaccurate values when used in multi-planar reconstruction when rotations are applied. In this scenario, the measurement tool's text may display inconsistent or incorrect length values. Inaccurate measurement values could compromise diagnostic accuracy and potentially lead to patient harm, including misdiagnosis or inappropriate follow-up.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)