Device product
Intelerad InteleShare software, with ProViewer component
Z-0941-2026
Product summary
- Firm
- DICOM Grid, Inc.
- Event
- Event 97993
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 924
- Official record key
device-enforcement:Z-0941-2026
Official wording
Reason: 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.
Code information: Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Distribution pattern: 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
Derived failure modes
-
Unknown
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.