Class IIOngoingZ-3171-2026
GE Healthcare recalls Core Services Hub V8
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
System, Image Processing, Radiological recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 20 recalls
Class IIOngoingZ-3170-2026
GE Healthcare recalls Workflow Core Services V8
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
Class IIOngoingZ-3169-2026
GE Healthcare recalls Centricity PACS Server V7
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
Class IIOngoingZ-3168-2026
GE Healthcare recalls Centricity PACS V2
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
Class IIOngoingZ-3167-2026
GE Healthcare recalls Enterprise Archive V8
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
Class IIOngoingZ-3166-2026
GE Healthcare recalls Centricity Enterprise Archive V2
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
GE HealthcareILSep 23, 2026
Class IIOngoingZ-3030-2026
FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310
Software issue may cause the ruler measurement to be inaccurate.
FUJIFILM Healthcare Am…MASep 2, 2026
Class IIOngoingZ-3004-2026
Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS
Software issue may cause measurements to be displayed inaccurately.
Merge Healthcare, Inc.WISep 2, 2026
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
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