FDA (Devices) recall action 82988
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.
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
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.
Collins Aerospace is recalling TASE 500 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.
Collins Aerospace is recalling 433 TASE 400 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.