FDA recall Z-2084-2019

Product

RX Imola, Model Nos. RX4900

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.

Key facts

Status

Terminated

Initiation date

2019-06-24

Report date

2019-07-31

Termination date

2020-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2084-2019