FDA-Device2025-12-24Class IIPROCESSING DEFECT

Intelerad InteleShare software recall for measurement inaccuracy in medical imaging

OTHERAK AL AR AZ CA CO CT DE FL GA IA ID IL IN KS LA MA MD MI MN MO NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV Medical devices

What this means

Intelerad InteleShare medical imaging software versions 3.24.3 through 3.25.2 contain a bug that can produce inaccurate measurement values when certain viewing features are used together. This could lead to incorrect measurements on medical images, potentially affecting diagnosis and treatment planning.

Check if your facility uses Intelerad InteleShare software versions 3.24.3–3.25.2
If affected, contact Intelerad for a software update or patch
Review recent measurements taken with multiplanar reconstruction and manual rotation enabled for accuracy

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

924

Manufactured in

305 Church At North Hills St, Raleigh, NC, United States

Products

Intelerad InteleShare software, with ProViewer component

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2026

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