FDA-Device2019-07-31Class II
RX Imola, Model Nos. RX4900
Randox Laboratories, Limited
Hazard
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
Sold states
Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
Affected count
27
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
RX Imola, Model Nos. RX4900
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2084-2019Don't want to check this manually?
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