Intelerad InteleShare software, with ProViewer component (DICOM Grid, Inc.) – software intended to aid in diagnosin... (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Intelerad InteleShare software, with ProViewer component
Brand
DICOM Grid, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
DICOM Grid, Inc. is recalling Intelerad InteleShare software, with ProViewer component due to Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met:. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
Recommended Action
Per FDA guidance
On 11/18/2025, correction notices were emailed to customers informing them of the following: 1) A stop deploy was issued for the affected versions. A software patch release will remove the use of measurements within the ProViewer when the user has both applied the MPR view and made a rotation on the plane. User manuals and guides will be updated to remove reference to this feature. 2) Until the update is applied, advise all staff to refrain from using measurements in MPR mode after rotating one of the planes. 3) Complete and return the acknowledgement form via email to email to regulatory-affairs@intelerad.com A software patch release to address this issue will be applied to all affected InteleShare servers between Nov 18-20th, 2025. There will be no service disruption associated with this release. For more information or to ask any questions about this notification, please contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.