FDA (Devices) recall action 74189
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.
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
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.
Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.
Ellipse A/S is recalling 25 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.