PlainRecalls

Siemens Medical Solutions USA, Inc

525 recalls on record · Latest: Feb 11, 2026

Siemens Medical Solutions USA, Inc Recall Insight

Siemens Medical Solutions USA, Inc appears on 525 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.625% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 11 critical, 39 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 47 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 10, 2023 to Feb 11, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 11, 2026

NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

FDA Devices Moderate Feb 11, 2026

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

FDA Devices Moderate Feb 4, 2026

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

FDA Devices Moderate Jan 14, 2026

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

FDA Devices Moderate Dec 10, 2025

MAMMOMAT Inspiration;

FDA Devices Moderate Dec 10, 2025

MAMMOMAT Fusion;

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…

FDA Devices Critical Oct 8, 2025

Biograph mMR. Model Number: 10433372.

FDA Devices Critical Oct 8, 2025

MAGNETOM Verio. Model Number: 10276755.

FDA Devices Critical Oct 8, 2025

MAGNETOM Lumina (DE). Model Number: 11344916.

FDA Devices Critical Oct 8, 2025

MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

FDA Devices Critical Oct 8, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Devices Critical Oct 8, 2025

MAGNETOM Vida Fit. Model Number: 11410481.

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra fit. Model Number: 10849580.

FDA Devices Critical Oct 8, 2025

MAGNETOM Cima.X (DE). Model Number: 11647158.

FDA Devices Critical Oct 8, 2025

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

FDA Devices Moderate Sep 17, 2025

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

FDA Devices Moderate Jun 25, 2025

UROSKOP Omnia Max. Model Number: 10762473

FDA Devices Moderate Feb 5, 2025

ARTIS One Angiographic X-Ray System

FDA Devices Moderate Oct 2, 2024

ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound …

FDA Devices Moderate Oct 2, 2024

ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, wi…

FDA Devices Moderate Oct 2, 2024

ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

FDA Devices Moderate Aug 14, 2024

LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

FDA Devices Moderate Aug 14, 2024

Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative to…

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and admin…

FDA Devices Moderate Jul 31, 2024

Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic an…

FDA Devices Moderate Jul 3, 2024

AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient de…

FDA Devices Moderate Jul 3, 2024

MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…

FDA Devices Moderate Jul 3, 2024

AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic d…

FDA Devices Moderate May 1, 2024

ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G

FDA Devices Moderate May 1, 2024

ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A

FDA Devices Moderate Apr 24, 2024

Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purp…

FDA Devices Moderate Jan 17, 2024

Sensis Vibe Hemo

FDA Devices Moderate Nov 22, 2023

Mobilett Mira wireless (VA20) mobile x-ray system(s)

FDA Devices Moderate Nov 8, 2023

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive i…

FDA Devices Moderate Nov 8, 2023

Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200

FDA Devices Moderate Oct 11, 2023

(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Mo…

FDA Devices Moderate Sep 20, 2023

ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

FDA Devices Moderate Aug 16, 2023

ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000

FDA Devices Moderate Aug 16, 2023

ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700

FDA Devices Moderate Aug 9, 2023

The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.…

FDA Devices Moderate Aug 2, 2023

Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Amb…

FDA Devices Moderate May 31, 2023

Luminos Agile Max (VE10, VF10, VF11)

FDA Devices Moderate May 31, 2023

Luminos dRF Max (VE10, VF10, VF11)

FDA Devices Moderate May 10, 2023

ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds