The Recall Desk

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.

401–425 of 796

  • HighFDA (Devices)·Z-1446-2018·2018-05-09

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1401-2018·2018-04-25

    Siemens Oncor Impression Plus Linear Accelerator Software Recall

    Siemens is recalling 15 Oncor Impression Plus linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2018·2018-04-25

    Siemens MEVATRON M2 Linear Accelerator Recalled for Collision Risk

    Siemens is recalling 18 MEVATRON M2 linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2018·2018-04-25

    Siemens ONCOR Impression Linear Accelerator Software Update Recall

    Siemens is recalling seven ONCOR Impression Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2018·2018-04-25

    Siemens Oncor Expression Linear Accelerator Software Update Recall

    Siemens is recalling two Oncor Expression linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2018·2018-04-25

    Siemens Oncor Avant-garde Linear Accelerator Software Update Recall

    Siemens is recalling one Oncor Avant-garde linear accelerator to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2018·2018-04-25

    Siemens PRIMUS HI Digital Linear Accelerator Software Recall

    Siemens is recalling 18 PRIMUS HI Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1303-2018·2018-04-11

    Siemens Syngo.via Software Recall for Incorrect Report Data

    Siemens is recalling Syngo.via software because it fails to save corrected report values, potentially sending outdated information to physicians.

    Product
    Syngo.via. Medical Device Software. Picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1261-2018·2018-04-04

    Siemens Syngo.via software recall due to data archiving configuration error

    Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.

    Product
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1148-2018·2018-03-28

    Siemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect

    Siemens is recalling 16 Artis one fluoroscopic x-ray systems because a missing or incorrect snap ring could cause the tabletop to slide to the floor.

    Product
    Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include car
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1150-2018·2018-03-28

    Siemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks

    Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.

    Product
    AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM 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 patien
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1065-2018·2018-03-21

    Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation

    Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.

    Product
    ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraopera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0713-2018·2018-03-07

    Siemens SOMATOM Go.Up CT Table Recall for Potential Instability

    Siemens Medical Solutions is recalling six SOMATOM Go.Up CT system tables because improperly tightened bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2018·2018-03-07

    Siemens CT Table Recalled Due to Potential Bolt Loosening and Instability

    Siemens Medical Solutions is recalling SOMATOM Go.Now CT system tables because bolts may loosen, causing the table to become unstable.

    Product
    SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2018·2018-03-07

    Siemens Medical Solutions Recalls Artis zee and Artis zeego Foot Switches

    Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.

    Product
    Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0708-2018·2018-03-07

    Siemens Axiom Artis Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Axiom Artis devices due to a potential for liquid entry.

    Product
    Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2018·2018-03-07

    Siemens Artis Zee and Zeego Medical Devices Recalled for Liquid Entry Risk

    Siemens Medical Solutions is recalling Artis Zee and Zeego devices due to a potential for liquid entry.

    Product
    Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2018·2018-03-07

    Siemens Medical Solutions Recalls Wireless Foot Switches for X-Ray Systems

    Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.

    Product
    Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0808-2018·2018-03-07

    Siemens Syngo.via Software Recall for Diagnostic Inconsistencies

    Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.

    Product
    Syngo.via systems with SW VB20A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2018·2018-03-07

    Siemens Axiom Artis Fluoroscopic Foot Switch Recalled for Potential Failure

    Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.

    Product
    Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0706-2018·2018-03-07

    Siemens Medical Solutions Recalls Artis Q and Q.Zen Systems

    Siemens Medical Solutions is recalling Artis Q and Q.Zen systems due to a potential for liquid entry.

    Product
    Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2018·2018-02-21

    Siemens Artis one X-ray Systems Recalled for Monitor Display Issues

    Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.

    Product
    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray gener
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0508-2018·2018-02-14

    Siemens Artis Biplane Systems Recalled for Ceiling Mount Defect

    Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.

    Product
    AArtis Q/ Q.Zen biplane Artis zee biplane 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
  • ModerateFDA (Devices)·Z-0524-2018·2018-02-14

    Siemens Syngo.plaza PACS Software Recall for Workflow Display Error

    Siemens is recalling 76 Syngo.plaza systems with SW VB20A because prior studies may not replace correctly in all workflow steps, potentially showing outdated images.

    Product
    Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2018·2018-02-07

    Siemens Syngo.plaza PACS Software Recalled for Data Security and Integrity Issues

    Siemens Medical Solutions is recalling 47 units of Syngo.plaza PACS software to fix data loss, study mix-ups, and unauthorized access risks.

    Product
    Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, di
    Category
    Medical Device
    Distribution
    Distributed nationwide