FDA recall Z-1964-2019

Product

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

Reason for recall

Potential for a transducer mis-alignment in certain transvaginal probes.

Distribution

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

Key facts

Status

Terminated

Initiation date

2019-07-02

Report date

2019-07-24

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2019