Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/4/2016
Class lI:
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.
Recall Number Z-1572-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountainview, CA on 9/5/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4
DISTRIBUTION
Germany, U.A.E., Hungary and Brazil.
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