Siemens

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.

The Siemens ARTIS icono floor medical imaging system may lose movement capability when the detector lift height is adjusted to its maximum or minimum position. This affects 30 units with specific serial numbers distributed nationwide.

Siemens Medical Solutions USA is recalling the ARTIS icono ceiling model 11328100 due to a potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits. This affects 119 units distributed nationwide.

Siemens Medical Solutions USA is recalling certain ARTIS icono biplane X-ray systems (Model 11327600) because the detector lift height may stop moving when adjusted to its maximum or minimum limits. This could prevent the equipment from operating normally during medical imaging procedures.

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.

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.

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.

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.

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.

Siemens Medical Solutions USA is recalling three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha.Pro CT systems. These applications were not cleared by the FDA before being distributed and must be removed from affected devices.

Siemens Medical Solutions distributed five CT imaging systems with three brain analysis software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) that did not receive required FDA 510(k) clearance before use. No injuries have been reported.

Siemens Medical Solutions has recalled three software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain NAEOTOM Alpha CT systems. These applications were not cleared by the FDA before being distributed, which is required for medical imaging software.

Siemens Medical Solutions has recalled three software applications (syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS) installed on certain SOMATOM X.ceed CT scanners because these applications were not cleared by the FDA before being distributed. Two CT systems are affected worldwide.

Certain Siemens LUMIOS Q.namix T interventional X-ray systems with software version VB10D-SP02 may fail to flip orthopedic images as intended when using automatic horizontal flip settings. In some cases, this could result in processing an image from a previous patient instead of the current one.

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.

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.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

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.

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.