Intelerad InteleShare software, with ProViewer component
Recall
- Recall Number
- Z-0941-2026
- Event Number
- 97993
- Firm
- DICOM Grid, Inc.
- FEI Number
- 3008776294
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- November 18, 2025
- Posted
- December 18, 2025
- Address
- 305 Church At North Hills St, Raleigh, NC, 27609-5177
Description
Intelerad InteleShare software, with ProViewer component
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.
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 [email protected] 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 [email protected]
US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SE
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