Agency classClass IIOur severity:High FDA (Devices)·Z-0331-2022·Announced 2021-12-08

Siemens Dimension Vista 500 software issue affects test accuracy

Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

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 3/5 (High).

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: This is an FDA Class II recall of a diagnostic device where software defects could affect test result accuracy and specimen quality assessment. No illnesses, injuries, or hospitalizations have been reported, but the device presents a risk-of-harm situation where inaccurate measurements could impact clinical decision-making.

Plain-English summary

The Siemens Dimension Vista 500 is an automated in-vitro diagnostic device used in clinical laboratories to analyze various analytes in human body fluids by duplicating manual procedures such as pipetting, mixing, heating, and measuring spectral intensities.

All software versions prior to 3.10.2 contain an incorrect default hemolysis, icterus, and lipemia (HIL) index for five specific assays. Hemolysis, icterus, and lipemia are conditions that can interfere with spectrophotometric measurements; an incorrect HIL index may result in inaccurate specimen quality assessment.

Approximately 1,326 units have been distributed worldwide, including throughout the United States and 20 countries in Europe, Asia, the Middle East, and Oceania. The recall affects all software versions prior to version 3.10.2, identified by GTIN numbers 00630414949581 and 00630414989556.

Siemens is providing a software update (version 3.10.2 or later) to correct the default HIL indices. Laboratories using the affected devices should update their software to ensure accurate specimen quality assessment and reliable test result reporting.

The recalled product

Product: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In-vitro diagnostic / Laboratory equipment
Hazard: measurement-error
software-defect
Affected units: 1,326

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, 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 Healthcare Diagnostics, Inc.

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