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.
FDA Recall Z-2771-2015 · Posted 2015-09-16
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Recalling FirmSony Medical Systems
Recall StatusTerminated
Product CodeFWB
Date Initiated2015-01-13
Date Terminated2017-04-26
Product Quantity4952 units (1016 US; 3936 OUS)
Reason for Recall
Tthe medical monitor has either not turned on or has lost image during clinical use.
Firm 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 directed to 866-789-SONY (7669) between 8:00 am and 8:00 pm Monday through Friday.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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