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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

882

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 281–300 of 882 recalls

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 1121953...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, ...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, au...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide

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• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, a...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Sensis/ Sensis Vibe Hemo systems with VD12A software as f...

Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions

FDAMar 4, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP...

SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

FDAMar 3, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: BCS XP System: Multipurpose system for in vitro coagulati...

Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

FDAMar 2, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Interventional Fluoroscopic X-Ray System - Product Usage:...

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

FDAFeb 26, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc: Enzyme linked immunosorbent assay, for herpes simplex vir...

Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.

FDAFeb 8, 2021AL, CA, FL +7 more• Siemens Healthcare Diagnostics, Inc

Siemens Medical Solutions USA, Inc.: Product Label - ACUSON Sequoia *** Power Input: 100-240V~...

The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.

FDAFeb 4, 2021AL, AK, AZ +41 more• Siemens Medical Solutions USA, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista HDLC - colorimetric method, lipoproteins ...

Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.

FDAFeb 3, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Sensis / Sensis Vibe systems with software version VD12 a...

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

FDAJan 27, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS Icono biplane Model:11327600 ARTIS Icono floor syst...

Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system

FDADec 18, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - In vitro diagnostic testing of...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

FDANov 30, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SOMATOM Force, Definition AS, Definition Edge, Definition...

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

FDANov 24, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product ...

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Produ...

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.