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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 261–280 of 882 recalls

Siemens Healthcare Diagnostics, Inc: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro di...

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

FDAJul 6, 2021Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Medical Solutions USA, Inc: Artis Models with SW version VD12 listed below: Artis zee...

Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment

FDAJun 30, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ARTIS pheno- angiography systems developed for single and...

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

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

Siemens Healthcare Diagnostics, Inc.: The ADVIA Chemistry XPT Chemistry System, Siemens Materia...

ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result

FDAMay 18, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - multi-component system for in...

Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - multi-component system for i...

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer- multi-component system for in...

FDAMay 13, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer with Photometer Lamp (SMN 110756...

Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results

FDAMay 4, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage:...

Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems

FDAApr 21, 2021Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Medical Solutions USA, Inc: Multitom RAX with software version VF10

Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.

FDAApr 20, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis systems - Product Usage: an angiography systems dev...

Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

FDAMar 30, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Artis zee ceiling-interventional Fluoroscopic X-Ray Syste...

Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

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

Siemens Medical Solutions USA, Inc: Interventional Fluoroscopic X-Ray System ARTIS icono bipl...

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

FDAMar 19, 2021Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Ysio X.pree, Model Number: 11107464 - Product Usage: A Di...

A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted

FDAMar 10, 2021Nationwide• Siemens Medical Solutions USA, Inc