DICOM Grid, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0941-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Intelerad InteleShare software, with ProViewer component

Product Classification:

Class II

Date Initiated: November 18, 2025

Date Posted: December 24, 2025

Recall Number: Z-0941-2026

Event ID: 97993

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.

Status: Ongoing

Product Quantity: 924

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

Voluntary or Mandated:

Voluntary: Firm initiated