PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 4, 2022 Initiated: March 7, 2022 #Z-1010-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
31 units
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.
Location
Issaquah, WA

Frequently Asked Questions

What product was recalled?
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 31 units.
Why was this product recalled?
Transducers (component of ultrasound system) may exceed recommended thermal index limits
Which agency issued this recall?
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-1010-2022.