Agency classClass IIOur severity:Severe FDA (Devices)·Z-1699-2018·Announced 2018-05-16

Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis

Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is FDA Class II and involves a medical device defect that could lead to patient misdiagnosis, which constitutes a significant injury risk. While no injuries are explicitly reported, the potential for serious harm justifies a Severe rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. has initiated a recall of Syngo.plaza software, specifically version VB10A with model numbers 10863171, 10863172, and 10863173. The company is issuing a software upgrade to correct errors in the format of study dates and to address issues with Legacy Presentation States, which include annotations.

Syngo.plaza is a Picture Archiving and Communication System (PACS) designed to display, process, read, report, communicate, distribute, store, and archive digital medical images. It supports physicians in diagnosis and treatment planning and integrates with Hospital/Radiology Information Systems (HIS/RIS). The recall affects 92 units distributed nationwide in the USA.

The primary reason for this recall is to prevent potential patient misdiagnosis resulting from the identified software defects. No specific illness or injury counts are reported in the source text, but the risk of misdiagnosis is significant.

The recalled product

Product: Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Software
Hazard: misdiagnosis
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

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