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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 361–380 of 882 recalls

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Total Bilirubin Flex reagent cartridge -In vit...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Total Bilirubin Flex reagent cartridge ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDA

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Page 19 of 45Next

Feb 13, 2020

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic f...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Ysio, model no. 10281013 Product Usage: The product is...

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

FDAFeb 10, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(...

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

FDAFeb 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(...

FDAFeb 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: ARTIS Pheno-Interventional Fluoroscopic X-Ray System Mod...

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

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

Siemens Medical Solutions USA, Inc: COHERENCE Oncologist, Model Nos. 07333680 & 07351898

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

FDAJan 16, 2020CA, FL, GA +13 more• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH Reaction Ring Segment, SMN 11099326, UDI 0063...

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

FDAJan 12, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: Uroskop Omnia max, Model No. 10762473 - Product Usage: Ur...

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, Model No. 10762472 - Product Usage: Lu...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Luminos dRF Max Model: 10762471- Pr...

Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max, model no. 10762471 - Product Usage: Lumi...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, model no. 10762471 - Product Usage: Lu...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Luminos Agile Max Model: 10762472 -...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Ysio Max, model no. 10762470 - Product Usage: The Ysio Ma...

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: SIEMENS Healthineers Uroskop Omnia max Model: 10762473 -...

FDAJan 8, 2020Nationwide• Siemens Medical Solutions USA, Inc