FDA recall Z-1138-2018

Product

MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

Reason for recall

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

Distribution

US distribution in the states: AZ, FL, OK, PA, and TX.

Key facts

Status

Terminated

Initiation date

2018-01-03

Report date

2018-03-28

Termination date

2019-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sesto Fiorentino, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2018