Manufacturer

Siemens Medical Solutions USA, Inc.

796 recalls in our database name Siemens Medical Solutions USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 796
Critical: 16
Severe: 69
Most recent: 2026-07-08

Of the 796 recalls from Siemens Medical Solutions USA, Inc. we have scored against our rubric, 16 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 69 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

326–350 of 796

ModerateFDA (Devices)·Z-1246-2019·2019-05-08
Siemens CT Scanner Recall for Potential Scan Abortion in Dual Mode
Siemens is recalling 53 SOMATOM Edge Plus CT scanners due to a software issue that may cause scans to abort when using the optional Dual Spiral Dual Energy mode.
Product
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2019·2019-05-01
Siemens Digital Linear Accelerators Recalled for Motion Protection Safety Advisory
Siemens Medical Solutions USA is recalling 120 digital linear accelerators nationwide to prevent patient or user injury from disabling the Automatic Motion Protection function.
Product
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software versio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2019·2019-04-17
Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk
Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.
Product
syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2019·2019-04-17
Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software
Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.
Product
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2019·2019-03-13
Siemens Uroskop Omnia Max Fluoroscopic X-ray System Recall for Swivel Arm Defect
Siemens is recalling 191 Uroskop Omnia Max fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
Product
Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0984-2019·2019-03-13
Siemens Uroskop Omnia Fluoroscopic X-ray System Recalled for Monitor Arm Defect
Siemens is recalling six Uroskop Omnia fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.
Product
Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0936-2019·2019-03-06
Siemens Sensis Vibe System Recalled for Software Crash Risk
Siemens Medical Solutions is recalling one Sensis Vibe System unit due to a software error that may cause system crashes during clinical procedures.
Product
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0707-2019·2019-01-16
Siemens Biograph Horizon PET/CT System Recalled for Design Defects
Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.
Product
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2019·2018-12-12
Siemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak
Siemens is recalling 64 Artis Zee and Zeego angiography systems due to a possible cooling hose leak that can cause the X-ray tube to overheat and block imaging.
Product
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0458-2019·2018-11-21
Siemens ARTIS Q Biplane Recalled for C-Arm Vibration Issues
Siemens is recalling 54 ARTIS Q biplane x-ray systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
Product
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Pro
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0459-2019·2018-11-21
Siemens Artis Q.zen Biplane X-Ray System Recalled for C-Arm Vibration
Siemens Medical Solutions is recalling 15 Artis Q.zen biplane angiographic x-ray systems because C-arm vibrations may reduce image quality.
Product
ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0457-2019·2018-11-21
Siemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues
Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.
Product
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patien
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0300-2019·2018-11-07
Siemens Ysio MAX Radiographic Systems Recalled for Cable Failure Risk
Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.
Product
Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0297-2019·2018-11-07
Siemens Multix Fusion Radiographic Systems Recalled for Lifting Column Cable Defect
Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.
Product
Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digita
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0298-2019·2018-11-07
Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk
Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.
Product
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0299-2019·2018-11-07
Siemens Ysio Radiographic Systems Recalled for Potential Tube Arm Drop
Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube arm to drop unexpectedly during patient positioning.
Product
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
Category
Medical Device
Distribution
38 states
ModerateFDA (Devices)·Z-0372-2019·2018-11-07
Siemens EVO Excel CT System Recalled for Mis-Labeled Current Limit
Siemens Medical Solutions is recalling 264 EVO Excel CT systems because the external ECG power-connection current limit is mis-labeled as 1.0A instead of 0.55A.
Product
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0178-2019·2018-10-24
Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.
Product
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2019·2018-10-24
Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.
Product
Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high res
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3189-2018·2018-09-26
Siemens Artis Q X-Ray Systems Recalled for Temperature Control Defect
Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.
Product
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3190-2018·2018-09-26
Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect
Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.
Product
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2837-2018·2018-08-29
Siemens 3D TOP Ceiling Stand Recalled for Potential Rope Failure
Siemens Medical Solutions is recalling 699 3D TOP Ceiling Stands because a load-bearing rope could break, causing the arm to drop and potentially seriously injure patients or users.
Product
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2838-2018·2018-08-29
Siemens 3D V Ceiling Stand Recalled for Potential Rope Failure
Siemens is recalling 3D V ceiling stands because the primary load-bearing rope could break, causing the arm to drop and potentially seriously injuring patients or users.
Product
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2747-2018·2018-08-22
Siemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue
Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
Product
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2748-2018·2018-08-22
Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue
Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
Product
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
Category
Medical Device
Distribution
Distributed nationwide