Recall Z-0941-2026
DICOM Grid, Inc. · initiated November 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Intelerad InteleShare software, with ProViewer component
Codes / lots: Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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
Details
- Recall number
- Z-0941-2026
- Initiated
- November 18, 2025
- Posted by FDA
- December 18, 2025
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 924
- Distribution
- 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
- Recalling firm
- DICOM Grid, Inc., Raleigh, NC