Recall Z-0941-2026— DICOM Grid, Inc.

Name: FDA recall Z-0941-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-18

Class II · Ongoing

Class II FDA medical device recall by DICOM Grid, Inc., initiated 2025-11-18. It names one FDA 510(k) clearance: K231360. Product: Intelerad InteleShare software, with ProViewer component. 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..

Recalling firm: DICOM Grid, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-18
Firm location: Raleigh, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K231360 — Ambra PACSDicom Grid Dba Ambra Health·cleared 2023-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Intelerad InteleShare software, with ProViewer component

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.