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 0 critical, 49 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 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 Dec 1, 2021 to May 3, 2023.

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 May 3, 2023

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600

FDA Devices Moderate Apr 5, 2023

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

FDA Devices Moderate Mar 1, 2023

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471

FDA Devices Moderate Mar 1, 2023

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

FDA Devices Moderate Mar 1, 2023

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

FDA Devices Moderate Mar 1, 2023

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

FDA Devices Moderate Mar 1, 2023

Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

FDA Devices Moderate Feb 22, 2023

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

FDA Devices Moderate Feb 22, 2023

SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

FDA Devices Moderate Feb 8, 2023

System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego …

FDA Devices Moderate Feb 1, 2023

Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Comput…

FDA Devices Moderate Jan 25, 2023

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

FDA Devices Moderate Jan 25, 2023

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

FDA Devices Moderate Jan 11, 2023

Programmable Diagnostic Computer

FDA Devices Moderate Dec 21, 2022

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear acc…

FDA Devices Moderate Sep 7, 2022

Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

FDA Devices Low Aug 24, 2022

AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis…

FDA Devices Moderate Jul 27, 2022

Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, …

FDA Devices Moderate Jul 13, 2022

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

FDA Devices Moderate Jul 13, 2022

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

FDA Devices Moderate Jul 6, 2022

Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

FDA Devices Moderate Jun 15, 2022

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

FDA Devices Moderate May 4, 2022

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

FDA Devices Moderate May 4, 2022

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upg…

FDA Devices Moderate May 4, 2022

syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade …

FDA Devices Moderate Apr 27, 2022

Artis zee floor MN, Model Number 10094142

FDA Devices Moderate Apr 27, 2022

Artis Q ceiling, Model Number 10848281

FDA Devices Moderate Apr 27, 2022

Artis Q zeego, Model Number 10848283

FDA Devices Moderate Apr 27, 2022

Artis Q.zen floor, Model Number 10848353

FDA Devices Moderate Apr 27, 2022

Artis zee biplane, Model Number 10094141

FDA Devices Moderate Apr 27, 2022

Artis zee multi-purpose, Model Number 10094139

FDA Devices Moderate Apr 27, 2022

Artis zee biplane MN, Model Number 10094143

FDA Devices Moderate Apr 27, 2022

SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All…

FDA Devices Moderate Apr 27, 2022

Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging …

FDA Devices Moderate Apr 27, 2022

Artis Q floor, Model Number 10848280

FDA Devices Moderate Apr 27, 2022

Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imagi…

FDA Devices Moderate Apr 27, 2022

Artis zee ceiling, Model Number 10094137

FDA Devices Moderate Mar 23, 2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the follow…

FDA Devices Moderate Feb 2, 2022

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

FDA Devices Moderate Feb 2, 2022

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

FDA Devices Moderate Feb 2, 2022

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

FDA Devices Moderate Jan 26, 2022

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # …

FDA Devices Moderate Jan 19, 2022

SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Devices Moderate Jan 19, 2022

SOMATOM Definition AS-Computed tomography system Model 8098027

FDA Devices Moderate Jan 19, 2022

SOMATOM Definition Edge -Computed tomography system Model 10590000

FDA Devices Moderate Jan 19, 2022

SOMATOM Confidence -Computed tomography systems Model 10590100

FDA Devices Moderate Jan 5, 2022

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. M…

FDA Devices Moderate Dec 1, 2021

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…

FDA Devices Moderate Dec 1, 2021

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model N…

FDA Devices Moderate Dec 1, 2021

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

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