Reported May 4, 2016 · Terminated
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON X700 Ultrasound System with software version 1.0.04
- Model numbers10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700
- Ultrasound System (Korea) RadiologyThe Siemens ACUSON X700 ultrasound imaging system is
- intended for the following applicationsCardiac (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
- Lot codes and dates
- Material (System)
- IVK Group Serial number10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714
- Amount recalled
- 4
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.
This product could cause temporary or reversible health problems — stop using it.
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