RX Daytona, Model Nos. RX4040 and RX4041
This recall has been terminated (originally issued June 24, 2019).
- Recall Initiated
- June 24, 2019
- Terminated
- May 21, 2020
- Recall Number
- Z-2083-2019
- Quantity
- 3
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.
Lot / Code Info
All serial numbers
Root Cause
Under Investigation by firm
Action Taken
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 technical.services@randox.com within five working days.