Siemens recalls

Siemens is recalling four ACUSON ultrasound imaging systems: ACUSON Orgin, ACUSON Orgin ICE, ACUSON Sequoia and ACUSON Sequoia Select. A software issue may cause the Color Doppler setting to activate unintentionally. That setting has not received FDA clearance, and the activation could cause the system to crash or become unresponsive. The recall was distributed in the US states of CA, CT, KY, NC and TX and in Germany, Italy and India.

Moderate·FDA·Nov 6, 20264 products

Four Siemens ARTIS imaging systems are in this recall: ARTIS icono biplane, ARTIS icono ceiling, ARTIS icono floor and ARTIS pheno. The systems may not carry out movement control commands as intended, and may show the message "Limited stand/table movement, SC." The affected units are in California, Kentucky, New York and Texas, and no injuries have been reported.

Moderate·FDA·Nov 6, 20264 products

Siemens is recalling two Atellica CH reagents: Atellica CH HDL Cholesterol (HDLC) and Atellica CH Total Protein_2 (TP_2). Reagent probe carryover on the Atellica CH and Atellica CI analyzers may cause falsely elevated Hemoglobin A1c results and falsely depressed Direct Bilirubin 2 results, which may affect patient samples, quality control, and calibrator results. No injuries have been reported, and the products were distributed in the US and many other countries.

Moderate·FDA·Nov 6, 20262 products

Siemens has recalled its Atellica CH Revised C-Reactive Protein (RCRP) test kit worldwide due to the potential for falsely elevated results. This diagnostic test is used in clinical laboratories to measure inflammation levels. Laboratories using affected lots may have received inaccurate test results.

Moderate·FDA·Oct 7, 2026

Siemens is recalling two quinidine assay kits, the Syva EMIT 2000 and the Beckman Coulter Emit 2000, because certain lots may give falsely high quinidine measurements. Quinidine is a heart and antimalarial drug, so inaccurate results could lead to inappropriate treatment. The recall covers 75 units total and was distributed in California and Italy.

Serious·FDA·Aug 26, 20262 products

Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.

Serious·FDA·Aug 26, 20262 products

Siemens Healthcare Diagnostics is recalling the Atellica CH Urine Albumin test (REF 11537225) used on CI analyzers. The test may produce falsely low urea nitrogen and hemoglobin A1c results, and may cause more quality control failures that delay results.

Moderate·FDA·Aug 12, 2026

Siemens Healthcare Diagnostics recalled Lot U2 of its Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls because the sodium azide concentration is outside specifications. The company says assay results were not affected, and the health risk to lab technicians is low, with the worst expected outcome being mild skin or eye irritation.

FDA·Aug 12, 2026

Siemens has identified a potential issue with the Display ceiling suspension (DCS Fix XL) component on ARTIS icono ceiling systems. Over time, screws that secure the monitor to the suspension may gradually loosen, which could affect the stability of the mounted display.

Moderate·FDA·Jul 8, 2026

Siemens is recalling three models of its ARTIS icono imaging systems, 234 units in total, because the detector lift may stop moving after it is adjusted to its highest or lowest height limit. No injuries have been reported.

Moderate·FDA·Jul 8, 20263 products

Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.

Moderate·FDA·Jun 17, 2026

Siemens has recalled certain ARTIS Pheno VE30A and VE40A imaging systems used in hospitals and medical facilities. During 3D imaging procedures, these systems may produce images with uneven brightness, potentially leading to less accurate reconstructions and unintended low-dose radiation exposure to patients.

Moderate·FDA·Apr 22, 2026

Siemens ARTIS pheno and ARTIS Icono biplane imaging systems may occasionally display an incorrect, higher x-ray dose reading during patient exams. The actual radiation dose delivered is safe and meets regulatory standards, but the displayed reading can be misleading. This affects certain model numbers used in hospitals and imaging centers.

Moderate·FDA·Apr 15, 2026

Siemens has recalled certain lots of its Atellica CH A1c_E hemoglobin test kit because when used with another reagent (RCRP) on the same analyzer, the A1c test may give lower-than-accurate results. Lower results could delay diabetes diagnosis or lead to inadequate treatment. This issue does not affect labs using separate analyzers for each test.

Moderate·FDA·Apr 8, 2026

Siemens Healthcare Diagnostics recalled its Atellica CH Urine Albumin test kits because they may report falsely low results for high-protein urine samples. If a sample contains more than 40.0 mg/dL of albumin, the test may incorrectly show a value between 6.2 and 40.0 mg/dL instead. This affects all lot numbers of Material Number 11537225 distributed worldwide.

Moderate·FDA·Mar 11, 2026

Siemens is recalling three brain imaging software applications installed on certain CT systems because they have not received FDA 510(k) clearance. The recall covers 4 CT system models, with 97 units affected, distributed in the US and Canada, Costa Rica, India, and Israel. No injuries have been reported.

Moderate·FDA·Feb 11, 20264 products

Certain Siemens interventional X-ray systems with software version VB10D-SP02 have a software issue that can cause images to display incorrectly. When the automatic image-flip feature is used, images may not flip as expected, and in some cases, a previous patient's image could appear instead of the current patient's image.

Moderate·FDA·Feb 4, 20262 products

Siemens LUMINOS Lotus Max and Luminos dRF Max X-ray systems with software version VF11 may show incorrect collimation (beam positioning) when quickly switching between organ programs. This affects only systems with a bucky wall stand for mobile detectors and no ceiling stand.

Moderate·FDA·Jan 14, 2026

Siemens is recalling 14 units across three MAMMOMAT mammography systems: Revelation, Inspiration, and Fusion. Some operator tables were sold together with a bus-installation kit, but they are designed only for stationary use and are not released for bus installations. No injuries have been reported.

Moderate·FDA·Dec 10, 20253 products

Siemens is recalling three IMMULITE allergen test products used with IMMULITE 2000 and IMMULITE 2000 XPi instruments. When paired with a Zebra barcode scanner, the barcode orientation can cause the instrument to misread the position of tubes in the allergen holder wedge. No injuries have been reported. The recall covers 2,864 units, with only one unit distributed in the US, and the rest sent to other countries.

Moderate·FDA·Nov 19, 20253 products

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDA·Nov 19, 2025