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Terminated

RX Imola, Model Nos. RX4900

FDA Recall Z-2084-2019 · Posted None

Recalling FirmRandox Laboratories, Limited
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-06-24
Date Terminated2020-05-21
Product Quantity27

Reason for Recall

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.

Firm Action

On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to [email protected] within five working days.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052914RX IMOLARandox Laboratories, Ltd. · 2006-03-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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