Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1027-2015·Announced 2015-02-04

Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes

Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.

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. The hazard involves potential data loss and database inconsistencies during system crashes, which is a significant operational risk but does not involve direct physical injury or death, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 50 units of the Syngo.plaza Picture Archiving and Communication System (PACS). The system is intended to display, process, read, report, communicate, distribute, store, and archive digital medical images to support physician diagnosis and treatment planning.

The recall is due to a software defect where images may not be written from the cache to the hard disk in the event of a system crash, such as a blue screen or power outage. This failure can result in the loss of images and inconsistencies in the database.

The affected units were distributed nationwide. Siemens Medical Solutions is the recalling firm. Consumers and healthcare facilities should contact Siemens Medical Solutions for further instructions on how to address this issue.

The recalled product

Product: Syngo.plaza: 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — PACS
Hazard: data-loss
software-defect
Affected units: 50

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 (4)

Model Numbers: 10592457
10863171
10863173
10863172

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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