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Recall Observatory FDA recall evidence

Device product

RX Imola, Model Nos. RX4900

Z-2084-2019

June 24, 2019

Class II

Product summary

Firm
Randox Laboratories, Limited
Event
Event 83175
Status
Terminated
Classification
Class II
Quantity
27
Official record key
device-enforcement:Z-2084-2019

Official wording

Reason: 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.

Code information: All serial numbers

Distribution pattern: Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.