Official recall notice

FDA DeviceClass IINotable

FDA Recall: Merge OrthoPACS, medical imaging diagnostic workstation

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Product description

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Affected products

UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.

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