Class IIOngoingZ-2875-2026
Merge Healthcare, Inc. recalls Merge OrthoPACS
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Merge Healthcare, Inc.WIAug 12, 2026
System, Image Processing, Radiological recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 44 recalls
Class IIOngoingZ-2874-2026
Merge Healthcare, Inc. recalls Merge PACS
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Merge Healthcare, Inc.WIAug 12, 2026
Class IIOngoingZ-2771-2026
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input.…
Boston Scientific Corp…MNJul 29, 2026
Class IIOngoingZ-2553-2026
GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g.…
GE Medical Systems SCSJul 1, 2026
Class IIOngoingZ-2068-2026
Mint Medical GmbH recalls Mint Lesion
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
Mint Medical GmbHMay 13, 2026
Class IIOngoingZ-1805-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical devi…
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding…
PHILIPS MEDICAL SYSTEM…Apr 22, 2026
Class IIOngoingZ-1692-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
PHILIPS MEDICAL SYSTEM…Apr 8, 2026
Class IIOngoingZ-1571-2026
GE Medical Systems, LLC recalls Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individ…
GE Medical Systems, LL…WIMar 25, 2026
Class IIOngoingZ-1570-2026
GE Medical Systems, LLC recalls Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individ…
GE Medical Systems, LL…WIMar 25, 2026
Class IIOngoingZ-1569-2026
GE Medical Systems, LLC recalls Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individ…
GE Medical Systems, LL…WIMar 25, 2026
Class IIOngoingZ-1475-2026
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on sy…
GE HealthcareILMar 11, 2026
Class IIOngoingZ-1243-2026
Focalyx Technologies, LLC. recalls Focalyx Fusion
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy…
Focalyx Technologies,…FLFeb 11, 2026