FDA-Device2022-05-04Class II
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Siemens Medical Solutions USA, Inc.
Hazard
Transducers (component of ultrasound system) may exceed recommended thermal index limits
Sold states
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.
Affected count
31 units
Manufactured in
22010 SE 51st St, Issaquah, WA, United States
Products
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief