FDA Medical Device Recalls (openFDA)
DICOM Grid, Inc.: Intelerad InteleShare software, with ProViewer component
- Recall number
- Z-0941-2026
- Recalling firm
- DICOM Grid, Inc.
- Product
- Intelerad InteleShare software, with ProViewer component
- Status
- Open, Classified
- Initiated
- 2025-11-18
- Posted
- 2025-12-18
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- On 11/18/2025, correction notices were emailed to customers informing them of the following: 1) A stop deploy was issued for the affected versions. A software patch release will remove the use of measurements within the ProViewer when the user has both applied the MPR view and made a rotation on the plane. User manuals and guides will be updated to remove reference to this feature. 2) Until the update is applied, advise all staff to refrain from using measurements in MPR mode after rotating one of the planes. 3) Complete and return the acknowledgement form via email to email to regulatory-affairs@intelerad.com A software patch release to address this issue will be applied to all affected InteleShare servers between Nov 18-20th, 2025. There will be no service disruption associated with this release. For more information or to ask any questions about this notification, please contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com
- Quantity
- 924
- 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
- Lot, serial or model codes
- Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
- 510(k) numbers
- K231360
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3008776294
- Firm city
- Raleigh
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28