FDA (Devices) recall action 91200
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.
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
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.
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.
Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.