| ARTIS icono biplane. Model Number: 11327600. recall (Z-2641-2026) | Siemens Medical Solutions USA, Inc | 2026-07-01 |
| ARTIS icono ceiling. Model Number: 11328100. recall (Z-2642-2026) | Siemens Medical Solutions USA, Inc | 2026-07-01 |
| ARTIS icono floor. Model Number: 11327700. recall (Z-2643-2026) | Siemens Medical Solutions USA, Inc | 2026-07-01 |
| ARTIS icono ceiling. Model Number: 11328100. recall (Z-2648-2026) | Siemens Medical Solutions USA, Inc | 2026-07-01 |
| ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system recall (Z-2205-2026) | Siemens Medical Solutions USA, Inc | 2026-06-04 |
| ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono c recall (Z-2206-2026) | Siemens Medical Solutions USA, Inc | 2026-06-04 |
| ARTIS Pheno VE30A and VE40A, Model 10849000 recall (Z-1814-2026) | Siemens Medical Solutions USA, Inc | 2026-04-16 |
| ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, recall (Z-1653-2026) | Siemens Medical Solutions USA, Inc | 2026-04-07 |
| SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperd recall (Z-1239-2026) | Siemens Medical Solutions USA, Inc | 2026-02-03 |
| NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperde recall (Z-1240-2026) | Siemens Medical Solutions USA, Inc | 2026-02-03 |
| NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel H recall (Z-1241-2026) | Siemens Medical Solutions USA, Inc | 2026-02-03 |
| NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyp recall (Z-1242-2026) | Siemens Medical Solutions USA, Inc | 2026-02-03 |
| Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN) recall (Z-1174-2026) | Siemens Medical Solutions USA, Inc | 2026-01-27 |
| Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN) recall (Z-1175-2026) | Siemens Medical Solutions USA, Inc | 2026-01-27 |
| LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 recall (Z-0999-2026) | Siemens Medical Solutions USA, Inc | 2026-01-08 |
| MAMMOMAT Revelation; recall (Z-0877-2026) | Siemens Medical Solutions USA, Inc | 2025-12-03 |
| MAMMOMAT Inspiration; recall (Z-0878-2026) | Siemens Medical Solutions USA, Inc | 2025-12-03 |
| MAMMOMAT Fusion; recall (Z-0879-2026) | Siemens Medical Solutions USA, Inc | 2025-12-03 |
| MAGNETOM Cima.X Upgrade. Model Number: 11689304. recall (Z-0431-2026) | Siemens Medical Solutions USA, Inc | 2025-11-12 |
| Biograph mMR. Model Number: 10433372. recall (Z-2654-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| BIOGRAPH One (DE). Model Number: 11689172. recall (Z-2655-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Cima.X (DE). Model Number: 11647158. recall (Z-2656-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Connectom.X. Model Number: 11371480. recall (Z-2657-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Lumina (DE). Model Number: 11344916. recall (Z-2658-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Prisma. Model Number: 10849582. recall (Z-2659-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K1 recall (Z-2660-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Skyra fit. Model Number: 10849580. recall (Z-2661-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. recall (Z-2662-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETO recall (Z-2663-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Verio. Model Number: 10276755. recall (Z-2664-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Verio Dot. Model Number: 10684333. recall (Z-2665-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Verio Dot Upgrade. Model Number: 10684334. recall (Z-2666-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K1 recall (Z-2667-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Vida Fit. Model Number: 11410481. recall (Z-2668-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| Artis Pheno. Image-Intensified Flouroscopic X-Ray System. recall (Z-2529-2025) | Siemens Medical Solutions USA, Inc | 2025-09-05 |
| ARTIS is a family of dedicated angiography systems developed for single and biplane diagno recall (Z-2019-2025) | Siemens Medical Solutions USA, Inc | 2025-06-27 |
| interventional fluoroscopic x-ray system recall (Z-2020-2025) | Siemens Medical Solutions USA, Inc | 2025-06-27 |
| interventional fluoroscopic x-ray system recall (Z-2021-2025) | Siemens Medical Solutions USA, Inc | 2025-06-27 |
| interventional fluoroscopic x-ray system recall (Z-2022-2025) | Siemens Medical Solutions USA, Inc | 2025-06-27 |
| UROSKOP Omnia. Model Number: 10094910 recall (Z-1981-2025) | Siemens Medical Solutions USA, Inc | 2025-06-17 |
| UROSKOP Omnia Max. Model Number: 10762473 recall (Z-1982-2025) | Siemens Medical Solutions USA, Inc | 2025-06-17 |
| ARTIS One Angiographic X-Ray System recall (Z-0922-2025) | SIEMENS MEDICAL SOLUTIONS USA, INC | 2025-01-29 |
| ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with softw recall (Z-3215-2024) | Siemens Medical Solutions USA, Inc. | 2024-09-24 |
| ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software recall (Z-3216-2024) | Siemens Medical Solutions USA, Inc. | 2024-09-24 |
| ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple recall (Z-3217-2024) | Siemens Medical Solutions USA, Inc. | 2024-09-24 |
| Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray patt recall (Z-2525-2024) | Siemens Medical Solutions USA, Inc | 2024-08-07 |
| Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray patter recall (Z-2526-2024) | Siemens Medical Solutions USA, Inc | 2024-08-07 |
| LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray patt recall (Z-2527-2024) | Siemens Medical Solutions USA, Inc | 2024-08-07 |
| Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern i recall (Z-2528-2024) | Siemens Medical Solutions USA, Inc | 2024-08-07 |
| Sensis Vibe systems with software version VD15B in combination with Sensis High End Server recall (Z-2438-2024) | Siemens Medical Solutions USA, Inc | 2024-07-25 |
| Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Mode recall (Z-2439-2024) | Siemens Medical Solutions USA, Inc | 2024-07-25 |
| Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Proc recall (Z-2440-2024) | Siemens Medical Solutions USA, Inc | 2024-07-25 |
| Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and ad recall (Z-2441-2024) | Siemens Medical Solutions USA, Inc | 2024-07-25 |
| AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction recall (Z-2180-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction recall (Z-2181-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction recall (Z-2182-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction recall (Z-2183-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency recall (Z-2184-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining em recall (Z-2185-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient tabl recall (Z-2186-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient tabl recall (Z-2187-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially recall (Z-2188-2024) | Siemens Medical Solutions USA, Inc | 2024-06-25 |
| ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diag recall (Z-1599-2024) | Siemens Medical Solutions USA, Inc. | 2024-04-19 |
| ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version V recall (Z-1600-2024) | Siemens Medical Solutions USA, Inc. | 2024-04-19 |
| ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 117117 recall (Z-1601-2024) | Siemens Medical Solutions USA, Inc. | 2024-04-19 |
| Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 1 recall (Z-1598-2024) | Siemens Medical Solutions USA, Inc | 2024-04-18 |
| Sensis Vibe Hemo recall (Z-0683-2024) | Siemens Medical Solutions USA, Inc | 2024-01-09 |
| ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 recall (Z-0523-2024) | Siemens Medical Solutions USA, Inc | 2023-12-09 |
| Mobilett Mira wireless (VA20) mobile x-ray system(s) recall (Z-0223-2024) | Siemens Medical Solutions USA, Inc | 2023-11-14 |
| Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgica recall (Z-0195-2024) | Siemens Medical Solutions USA, Inc | 2023-10-27 |
| ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designe recall (Z-0196-2024) | Siemens Medical Solutions USA, Inc | 2023-10-27 |
| (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, M recall (Z-2648-2023) | Siemens Medical Solutions USA, Inc | 2023-09-29 |
| ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 recall (Z-2582-2023) | Siemens Medical Solutions USA, Inc. | 2023-09-13 |
| ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imagi recall (Z-2359-2023) | Siemens Medical Solutions USA, Inc | 2023-08-08 |
| ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging recall (Z-2360-2023) | Siemens Medical Solutions USA, Inc | 2023-08-08 |
| ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and in recall (Z-2361-2023) | Siemens Medical Solutions USA, Inc | 2023-08-08 |
| The following Pro.specta Emission Computed Tomography Systems that were manufactured with recall (Z-2256-2023) | Siemens Medical Solutions USA, Inc. | 2023-07-28 |
| Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traum recall (Z-2240-2023) | Siemens Medical Solutions USA, Inc | 2023-07-27 |
| Luminos Agile Max (VE10, VF10, VF11) recall (Z-1479-2023) | Siemens Medical Solutions USA, Inc | 2023-05-23 |
| Luminos dRF Max (VE10, VF10, VF11) recall (Z-1480-2023) | Siemens Medical Solutions USA, Inc | 2023-05-23 |
| LUMINOS Lotus Max (VF11) recall (Z-1481-2023) | Siemens Medical Solutions USA, Inc | 2023-05-23 |
| ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiog recall (Z-1498-2023) | Siemens Medical Solutions USA, Inc | 2023-05-02 |
| ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and recall (Z-1469-2023) | Siemens Medical Solutions USA, Inc | 2023-04-27 |
| ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluorosc recall (Z-1311-2023) | Siemens Medical Solutions USA, Inc | 2023-03-30 |
| Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoro recall (Z-1164-2023) | Siemens Medical Solutions USA, Inc | 2023-02-23 |
| Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic recall (Z-1165-2023) | Siemens Medical Solutions USA, Inc | 2023-02-23 |
| Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluorosco recall (Z-1166-2023) | Siemens Medical Solutions USA, Inc | 2023-02-23 |
| Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiograph recall (Z-1167-2023) | Siemens Medical Solutions USA, Inc | 2023-02-23 |
| Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic recall (Z-1168-2023) | Siemens Medical Solutions USA, Inc | 2023-02-23 |
| SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission recall (Z-1134-2023) | Siemens Medical Solutions USA, Inc. | 2023-02-13 |
| SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) recall (Z-1135-2023) | Siemens Medical Solutions USA, Inc. | 2023-02-13 |
| SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge recall (Z-1136-2023) | Siemens Medical Solutions USA, Inc. | 2023-02-13 |
| System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purp recall (Z-1040-2023) | Siemens Medical Solutions USA, Inc | 2023-01-30 |
| AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF recall (Z-1000-2023) | Siemens Medical Solutions USA, Inc | 2023-01-20 |
| AXIOM Luminos Agile recall (Z-1001-2023) | Siemens Medical Solutions USA, Inc | 2023-01-20 |
| Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max recall (Z-1002-2023) | Siemens Medical Solutions USA, Inc | 2023-01-20 |
| Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNe recall (Z-1003-2023) | Siemens Medical Solutions USA, Inc | 2023-01-20 |
| ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor recall (Z-0956-2023) | Siemens Medical Solutions USA, Inc | 2023-01-13 |
| Programmable Diagnostic Computer recall (Z-0775-2023) | Siemens Medical Solutions USA, Inc | 2023-01-01 |
| ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Materia recall (Z-0472-2023) | Siemens Medical Solutions USA, Inc | 2022-12-09 |