FDA (Devices) recall action 86440
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.
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
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.
Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.
Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.