Summary
The FDA issued a Class II for Intelerad InteleShare software, with ProViewer component by DICOM Grid, Inc.. Reason: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met:.
Details
Source
Device Recall
External ID
Z-0941-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
Intelerad InteleShare software, with ProViewer component
Lot/Code Info: Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Quantity Affected: 924
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-18
Company
Raleigh, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DICOM Grid, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DICOM Grid, Inc. have FDA actions?
This is the only FDA action we have on record for DICOM Grid, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0941-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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