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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 681–700 of 882 recalls

Siemens Healthcare Diagnostics, Inc.: Siemens Stratus CS Acute Care Troponin I CalPak. In vitr...

The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

FDAApr 28, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge C-Reactive Protein Exten...

falsely elevated results in EDTA plasma samples

FDAApr 15, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Cardiac Troponin I Flex reagent cartridge (CTN...

possibility of falsely elevated results

1...33 343536 37...45

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FDAApr 8, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions Diagnostics: In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test...

False negative hCG results due to decreased sensitivity

FDAApr 4, 2008Nationwide• Siemens Medical Solutions Diagnostics

Siemens Healthcare Diagnostics Inc.: Dimension Total Prostate Specific Antigen (TPSA) Flex Rea...

False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

FDAMar 24, 2008Nationwide• Siemens Healthcare Diagnostics Inc.

Siemens Medical Solutions USA, Inc.: ACUSON Antares 5.0 ultrasound system at SW revision 200.0...

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

FDAMar 21, 2008AZ, CA, FL +33 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc.: Sonoline Antares 5.0 ultrasound system at SW revision 200...

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

FDAMar 21, 2008AZ, CA, FL +33 more• Siemens Medical Solutions USA, Inc.

Siemens Medical Solutions USA, Inc: Syn go Imaging XS is a picture archiving and communicatio...

The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.

FDAMar 10, 2008AL, AZ, CA +26 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Update Instructions "TH003/08/S" applies to Siemens brand...

The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.

FDAMar 10, 2008Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions, USA, Inc: Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; ...

Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.

FDAFeb 8, 2008Nationwide• Siemens Medical Solutions, USA, Inc