Imaging viewer software recalled over inaccurate length measurement values
DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states the bug could compromise diagnostic accuracy and lead to misdiagnosis, and no injuries are reported.
Plain-English summary
Intelerad InteleShare software with the ProViewer component is being recalled by DICOM Grid, Inc. The software is intended to aid in diagnosing conditions, planning treatments and visualizing anatomical structures.
The software has a bug that, if all of the following are met, could result in inaccurate length measurement tool values: viewing images in the InteleShare viewer, multiplanar reconstruction applied, and manual rotation applied. The firm states this could compromise diagnostic accuracy and lead to misdiagnosis or inappropriate follow-up.
The record lists 924 units, covering software versions 3.24.3 to 3.25.2 under UDI-DI B228INTELESHARE0, with a first distribution date of 2024-08-28. Distribution covered Arizona, Texas, Georgia, Nevada, Missouri, Michigan, Illinois, Ohio, Connecticut, Oregon, Florida, New York, New Mexico, Minnesota, Pennsylvania, Alaska, North Dakota, New Jersey, Virginia, Washington, North Carolina, Tennessee, Wisconsin, California and South Dakota. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites should follow the firm's instructions.
The recalled product
- Product
- Intelerad InteleShare software, with ProViewer component
- Manufacturer
- DICOM Grid, Inc.
- Affected units
- 924
Distribution
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