Z-1572-2016Class II

ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound...

Name: Z-1572-2016 ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2015-09-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-09-05 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System... on 2015-09-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1572-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-05
Posted: 2016-04-27
Terminated: 2016-04-27
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 4
Distribution: Distributed in Germany, U.A.E., Hungary and Brazil.
Product codes and lots: Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1572-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1572-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code IYN

K123001Class IIAcuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2012-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)