Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues
Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or specific safety hazards, indicating a precautionary or minor software correction.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 104 units of the Syngo.x Picture Archiving and Communication System (PACS). The recall is being conducted to install software changes that address several issues with the system. The affected devices are distributed nationwide.
The Syngo.x system is a software solution used for viewing, manipulating, communicating, and storing medical images in healthcare environments such as Radiology, Nuclear Medicine, and Cardiology. The specific nature of the issues being addressed by the software changes is not detailed in the source text.
Healthcare facilities that have installed these specific model and serial numbers should contact Siemens Medical Solutions USA, Inc. to obtain the necessary software updates. The recall number is Z-1688-2017.
The recalled product
- Product
- Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 104
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 (2)
- Device Model Numbers: 10863171
- 10863172
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 →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens Syngo.plaza PACS Software Recall for Issue Resolution
FDA (Devices) · 2017-02-08
- ModerateSiemens Syngo.plaza PACS Software Recall for Multiple Issues
FDA (Devices) · 2016-10-05
- ModerateSiemens Syngo.plaza PACS Systems Recalled for Software Update Issues
FDA (Devices) · 2017-03-29
- HighSiemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues
FDA (Devices) · 2018-02-07
- HighSiemens Syngo.plaza PACS Recalled for Potential Data Loss and Mix-ups
FDA (Devices) · 2015-09-09
- ModerateSiemens Syngo.x Software Recalled for Incorrect Volume Calculations
FDA (Devices) · 2016-09-28