[pending] Intelerad InteleShare software, with ProViewer component
Pending LLM rewrite. Source: FDA_DEVICE Z-0941-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Intelerad InteleShare software, with ProViewer component
- Manufacturer
- DICOM Grid, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 45 states:
- AK
- 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
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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