FDA (Devices) recall action 99391
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.
Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.