FDA Device recall Z-1572-2016
ACUSON X700 Ultrasound System with software version 1.0.04
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of ACUSON X700 Ultrasound System with software version 1.0.04 by Siemens Medical Solutions Usa, citing 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 messa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1572-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-05 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559…Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1572-2016%22
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