Agency classClass IIOur severity:High FDA (Devices)·Z-1700-2018·Announced 2018-05-16

Siemens Syngo.plaza Software Recalled to Prevent Patient Misdiagnosis

Siemens Medical Solutions is recalling 92 units of Syngo.plaza software to fix date formatting and annotation issues that could lead to patient misdiagnosis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury (misdiagnosis) has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 92 units of Syngo.plaza software, a Picture Archiving and Communication System (PACS) used to display, process, and archive digital medical images. The recall is being conducted to correct the format of study dates and resolve issues with Legacy Presentation States (annotations).

The software is intended to support physicians in diagnosis and treatment planning. The identified defects pose a risk of potential patient misdiagnosis if the incorrect dates or annotations are relied upon during clinical review. The recall covers all serial numbers and is distributed nationwide in the United States.

Healthcare facilities using this software should contact Siemens Medical Solutions USA, Inc. for instructions on how to obtain the software upgrade. The upgrade will correct the date formatting and annotation issues to ensure accurate image presentation.

The recalled product

Product: 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Software
Hazard: misdiagnosis
software-defect
Affected units: 92

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Serial Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · misdiagnosis