Home / Brands / Siemens Medical Solutions USA
Siemens Medical Solutions USA Recalls
796 recalls on record · August 1, 2012 to July 8, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This comput
Hazard: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This compu
Hazard: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This compu
Hazard: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed
Hazard: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
July 10, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Hazard: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
May 22, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated a
Hazard: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
May 22, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated a
Hazard: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
May 22, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography syste
Hazard: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
May 22, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicat
Hazard: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
May 15, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed
Hazard: Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
May 15, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mob
Hazard: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
May 8, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098
Hazard: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
May 8, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process
Hazard: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
May 8, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and p
Hazard: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
May 8, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and proces
Hazard: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
May 1, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR
Hazard: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
April 17, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Ca
Hazard: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
April 17, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Ca
Hazard: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
March 13, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize a
Hazard: The swivel arm holding the monitors may become dislodged from the carrying arm.