Recall Z-1010-2022— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1010-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-07

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2022-03-07. It names one FDA 510(k) clearance: K211859. Product: Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,. Reason: Transducers (component of ultrasound system) may exceed recommended thermal index limits.

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-07
Firm location: Issaquah, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K211859 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.·cleared 2021-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.