FDA (Devices) recall action 71923
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
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.
Toshiba is recalling 459 Aquilion CT Systems because specific scanning operations may prevent raw data from being saved.
Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.