Z-0941-2026Class II

Intelerad InteleShare software, with ProViewer component

Name: Z-0941-2026 Intelerad InteleShare software, with ProViewer component
Creator: DICOM Grid, Inc.
Published: 2025-11-18
License: https://open.fda.gov/license/

DICOM Grid (dba Ambra Health) / initiated 2025-11-18 / Open, Classified / root cause: software

FDA source

DICOM Grid, Inc. began a recall of Intelerad InteleShare software, with ProViewer component on 2025-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0941-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-18
Posted: 2025-12-18
Recalling firm: DICOM Grid (dba Ambra Health)
Product: Intelerad InteleShare software, with ProViewer component
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 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
Product codes and lots: Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code LLZ

K231360Class IIAmbra PACSDicom Grid Dba Ambra Health / cleared 2023-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)