FDA (Devices) recall action 89176
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.
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
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.
Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.
Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.