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.
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
MAMMOMAT Inspiration;
MAMMOMAT Fusion;
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…
Biograph mMR. Model Number: 10433372.
MAGNETOM Verio. Model Number: 10276755.
MAGNETOM Lumina (DE). Model Number: 11344916.
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
MAGNETOM Vida Fit. Model Number: 11410481.
MAGNETOM Skyra fit. Model Number: 10849580.
MAGNETOM Cima.X (DE). Model Number: 11647158.
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
interventional fluoroscopic x-ray system
interventional fluoroscopic x-ray system
interventional fluoroscopic x-ray system
UROSKOP Omnia Max. Model Number: 10762473
ARTIS One Angiographic X-Ray System
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 …
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, wi…
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative to…
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and admin…
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic an…
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…
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…
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…
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purp…
Sensis Vibe Hemo
Mobilett Mira wireless (VA20) mobile x-ray system(s)
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive i…
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Mo…
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.…
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Amb…
Luminos Agile Max (VE10, VF10, VF11)
Luminos dRF Max (VE10, VF10, VF11)
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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