FDA recall Z-1010-2022

Siemens Medical Solutions USA, Inc. · Class II · device

Product

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

Reason for recall

Transducers (component of ultrasound system) may exceed recommended thermal index limits

Distribution

Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand.

Key facts

Status: Ongoing
Initiation date: 2022-03-07
Report date: 2022-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Issaquah, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2022