Siemens Medical Solutions USA, Inc. recalls ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 106…

Recall date

September 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1572-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Distributed in Germany, U.A.E., Hungary and Brazil.

Why it was recalled

Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.