Recall Z-2321-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-2321-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2015-06-25, terminated 2017-10-19. It names one FDA 510(k) clearance: K132804. Product: ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.. Reason: Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-25
Terminated: 2017-10-19
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132804 — ACUSON S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro·cleared 2013-10-24

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 S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Reason for recall

Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.

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