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Recall Observatory FDA recall evidence

Device product

Sony Medical Monitor LMD-1951MD 19 inch

Z-1514-2015

March 05, 2015

Class II

Product summary

Firm
Sony Latin America
Event
Event 70702
Status
Terminated
Classification
Class II
Quantity
4,764 units
Official record key
device-enforcement:Z-1514-2015

Official wording

Reason: Monitor has either not turned on or has lost image during clinical use.

Code information: Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.

Distribution pattern: Worldwide Distribution - US Distribution to the states of : FL and NC., and to the countries of : Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, Dominican Republic, and South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Monitor has either not turned on or has lost image during clinical use.