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Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc Recalls

All product recalls associated with Siemens Medical Solutions USA, 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 141–160 of 882 recalls

Siemens Medical Solutions USA, Inc: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Mechanical connection between the tabletop and table base may be lost.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: System Material # Artis zee floor 10094135 Artis zee cei...

In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

FDADec 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics Inc: epoc Host 2 as follows: Product SMN epoc ...

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

1...6 789 10...45

Page 8 of 45Next

FDA

Dec 12, 2022

Nationwide

• Siemens Healthcare Diagnostics Inc

Siemens Medical Solutions USA, Inc: AXIOM Luminos Agile

There is potential for the footrest to detach from the patient table during use.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 an...

There is potential for the footrest to detach from the patient table during use.

FDADec 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnosti...

Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnosti...

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: LUMINOS Lotus Max (VF11)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos Agile Max (VE10, VF10, VF11)

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Luminos dRF Max (VE10, VF10, VF11)

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Programmable Diagnostic Computer

The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

FDANov 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with s...

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

FDANov 9, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Ki...

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

FDANov 4, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE and IMMULITE 1000 Total Testosterone Assay- In v...

Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

FDAOct 25, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions USA, Inc: ARTIS pheno, Interventional fluoroscopic x-ray system, Mo...

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

FDASep 20, 2022Nationwide• Siemens Medical Solutions USA, Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH Lithium (Li), Siemens Material Number 1109753...

Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 1...

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

SIEMENS HEALTHCARE DIAGNOSTICS INC: N Antiserum to Human IgG, 2mL Variant for BN II System an...

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

SIEMENS HEALTHCARE DIAGNOSTICS INC: N Antiserum to Human IgG, 5mL Variant for BN II System an...

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC