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Recall Observatory FDA recall evidence

Device product

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.

Z-2771-2015

January 13, 2015

Class II

Product summary

Firm
Sony Medical Systems
Event
Event 71657
Status
Terminated
Classification
Class II
Quantity
4952 units (1016 US; 3936 OUS)
Official record key
device-enforcement:Z-2771-2015

Official wording

Reason: Tthe medical monitor has either not turned on or has lost image during clinical use.

Code information: Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145 Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tthe medical monitor has either not turned on or has lost image during clinical use.