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.
What this means for you
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 base
- 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.
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