Home / Recalls / Siemens Medical Solutions USA, Inc / Z-1700-2018

Z-1700-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1700-2018 was initiated by Siemens Medical Solutions USA, Inc on Feb 20, 2018 and is designated Class II. Reason for recall: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. The recall status is terminated (terminated Jul 16, 2019). Affected quantity: 92.

Recall Details

Product Type: Devices
Report Date: May 16, 2018
Initiation Date: Feb 20, 2018
Termination Date: Jul 16, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 92

Product Description

Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

Reason for Recall

Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

Distribution Pattern

USA (nationwide)

Code Information

All Serial Numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1700-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.