Recall Z-0941-2026 ยท LLZ System, Image Processing, Radiological
DICOM Grid, Inc.
Intelerad InteleShare software, with ProViewer component
| Date | Dec 18, 2025 (initiated Nov 18, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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-af |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231360 | Ambra PACS Dicom Grid Dba Ambra Health, Jun 7, 2023 |