The Recall Desk
HighFDA (Devices)·Z-2719-2015·Announced 2015-09-09

Siemens Syngo.plaza PACS Recalled for Potential Data Loss and Mix-ups

Siemens Medical Solutions is recalling 37 Syngo.plaza PACS units due to a potential issue that could lead to data loss and patient data mix-ups.

What this means for you

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 imaging system) where data integrity issues could impact patient care, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 37 units of the Syngo.plaza Picture Archiving and Communications System (PACS). The recall is being conducted due to a potential issue that could lead to data loss and patient data mix-ups.

The affected devices are Model Number 10592457 with specific serial numbers listed in the recall documentation. These units were distributed nationwide in the United States, specifically in the states of California, Oregon, Florida, Missouri, New York, Washington, Maryland, Massachusetts, Wisconsin, Kansas, Minnesota, and Pennsylvania.

The Syngo.plaza system is intended to display, process, read, report, communicate, distribute, store, and archive digital medical images to support physicians in diagnosis and treatment planning. Users of these systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and remediation of the identified issue.

The recalled product

Product
Syngo.plaza; picture archiving and communications system Product Usage: 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
Affected units
37

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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