FDA (Devices) recall action 69970
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The recalled devices labeling and instructions for use contain unapproved medical claims.
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.
Arjo Hospital Equipment AB is recalling 226 Rotoprone Therapy Systems because their labeling and instructions for use contain unapproved medical claims.
Arjo Hospital Equipment AB is recalling 567 TriaDyne Proventa Critical Care Therapy Systems because their labeling and instructions for use contain unapproved medical claims.
Arjo Hospital Equipment AB is recalling 271 RotoRest Delta Advanced Therapy Systems because their labeling contains unapproved medical claims.