Important Safety Alerts
Medical Device Safety Alert: SONY LMD-1951MD Monitors used with SpyGlass
12 Mar 2015
Medical device manufacturer, Boston Scientific, on behalf of Sony Electronics Inc., has issued a field safety notice concerning specific SONY LMD-1951MD Monitors (material numbers: M00546120, M0054612S0, M0054612Z0) used with SpyGlass.
According to the manufacturer, the Monitor may either not turn on, or may lose image during use in some situations. The issue is the result of a potential disconnection of the internal power supply caused by a failure of a power board integrated circuit. The failure mode does not occur when an AC adapter is used with the monitor.
As a precautionary measure, the manufacturer asks all users to take the following actions.
- If users possess an AC adapter for each of the affected monitors, use only the AC adaptor when the monitors are in use.
- Users who do not possess an AC adapter for each of the affected monitors should stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.
As a permanent corrective action, the manufacturer will replace the power board of all affected units with a redesigned power board that does not exhibit this failure mode.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 March 2015