Recall Z-2771-2015 ยท FWB Camera, Television, Surgical, Without Audio
Sony Medical Systems
Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
| Date | Sep 16, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | Tthe medical monitor has either not turned on or has lost image during clinical use. |
| Root cause | Device Design |
| Action | Sony Corporation sent an URGENT: MEDICAL DEVICE FIELD ACTION field letter dated January 13, 2015. Customers are asked to affix the warning sticker to the rear of the monitor and place the adhesive seal over the AC inlet. If the firm does not possess an AC adaptor (AC-110MD) for each of the affected monitors, stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit the appropriate failure mode. Questions can be di |
| Quantity | 4952 units (1016 US; 3936 OUS) |
| Distribution | Worldwide Distribution - US Distribution to the states of : AZ, CA, NC, PA, IA, OH and FL., and to the countries of : China, Japan, Taiwan, South Korea and Indonesia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.