—#145322

Product

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123001
Affected lot / code info: Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714

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.

Root cause (FDA determination)

Software design

Action the firm took

September 5, 2015 we initiated a correction via update program US020/15/S where we visited all four units and updated their software to version 1.0.05

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

Distribution pattern: Distributed in Germany, U.A.E., Hungary and Brazil.

Timeline

Recall initiated: 2015-09-05
Terminated: 2016-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.