The FDA has posted 20 enforcement recalls of radiological image processing system devices since 2025, none of them Class I (most serious). Most recent report: Sep 23, 2026.
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient.…
Software issue may cause measurements to be displayed inaccurately.
Software issue may cause the ruler measurement to be inaccurate.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
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.…
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.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“System, Image Processing, Radiological”). Informational only — verify against the FDA before acting.