Merge PACS

Evidence summary

The K192455 FDA decision summary describes Merge PACS support for CT, MR, PET, ultrasound, mammography, breast tomosynthesis, CR, DR/DX, nuclear medicine, XA, RF, and secondary-capture image workflows, with professional diagnostic review and reporting. Because the cleared scope spans many modalities, the directory preserves a variable or unspecified modality rather than forcing one modality label; no AI classifier sensitivity or specificity is established.

FDA source Exact FDA submission Checked 2026-09-03

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No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

4 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K192455. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-3004-2026 is Open, Classified for Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation. FDA reason: Software issue may cause measurements to be displayed inaccurately. FDA action: Merge Healthcare issued an Urgent Field Safety Notice to its consignees on 7/22/2026 via email with a follow-up telephone call. The notice explained the issue and how to identify it, risk to patient, and requested the following: "Immediate actions to reduce risk to patients Merge Healthcare recommends that customers contact Merge Healthcare Support to identify any affected ultrasound studies and the necessary next steps to be taken. Until the software update is installed, ultrasound measurements performed using the Merge PACS & OrthoPACS Viewer should be confirmed against the measurements acquired at the ultrasound modality." The required actions are as follows: "Merge Healthcare Support will contact all customers to: i) Confirm that you have read and understood this Urgent Field Safety Notice. ii) Assist you in identifying and reviewing any ultrasound studies with measurements that may have been affected. iii) Schedule the installation of the software update that eliminates the root cause of this issue. Please forward this notice to any individuals within the organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. FDA recall Z-2874-2026 is Open, Classified for Merge PACS, medical imaging diagnostic workstation. FDA reason: Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. FDA action: Merge Healthcare issued an Urgent Field Safety Notice (Revision 2) to its consignees on 6/30/2026 via email. The notice explained the issue and when it may occur, risk to patient, and requested an immediate workaround, a configuration change, be performed to disable automatic refresh of the Thumbnail Bar until a software update is available. The notice also directions the consignee to forward the notice to any individuals within their organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The notice was followed by telephone calls beginning on 7/6/2026 to ensure the notice was received. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. FDA recall Z-2875-2026 is Open, Classified for Merge OrthoPACS, medical imaging diagnostic workstation. FDA reason: Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. FDA action: Merge Healthcare issued an Urgent Field Safety Notice (Revision 2) to its consignees on 6/30/2026 via email. The notice explained the issue and when it may occur, risk to patient, and requested an immediate workaround, a configuration change, be performed to disable automatic refresh of the Thumbnail Bar until a software update is available. The notice also directions the consignee to forward the notice to any individuals within their organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Urgent Field Safety Notice. The notice was followed by telephone calls beginning on 7/6/2026 to ensure the notice was received. For more information, please contact Merge Healthcare Support at 1-877-741-5369 (available 24 hours a day, 7 days a week) or visit our website: https://www.merative.com/support/merge. FDA recall Z-2944-2020 is Terminated for Merge PACS. FDA reason: Measurements done on the Merge PACS generated MPR s may have incorrect measurements. FDA action: The firm, IBM Watson Health, sent an "Urgent Field Safety Notice" dated 05 August 2020 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: Avoid incorrect pixel measurements by using the following workflow: Step 1: Modality acquires a series and generates reformat and sends to Merge PACS Step 2: Radiologist performs measurement on these series from the modality. Avoid black dots that may lead to additional imaging by taking any of the following actions: - Verifying study images either at modality or in another viewer. - Increasing the window level will window out the lowest pixel value (the black dots). - Viewing additional images/series within the study. Viewing of prior series/studies. - Verifying patients history, diagnosis or other clinical data. IBM Watson Health/Merge Healthcare will provide a software correction to address these issues. A representative will be in contact with you to schedule the software update. Please ensure all potential users of Merge PACS v8.1, 8.1.1 and 8.1.2 have received this notice. Please provide this notice to other organizations impacted by this action. If you have any questions regarding this notice, please contact Customer Support at WHISupport@us.ibm.com or 877-741-5369.

FDA source Exact FDA submission Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 4 FDA recall candidates were manually reviewed: 4 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 4 postmarket candidate records; 4 have been reviewed (4 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision summary K192455: Merge PACS U.S. Food and Drug Administration · 2026-09-03
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-3004-2026: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2874-2026: Merge PACS, medical imaging diagnostic workstation U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2875-2026: Merge OrthoPACS, medical imaging diagnostic workstation U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2944-2020: Merge PACS U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Merge PACS Merative · 2026-09-03