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Siemens Medical Solutions USA Recalls
796 recalls on record · August 1, 2012 to July 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray t
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transm
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transm
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray tran
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmi
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray tran
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transm
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmis
Hazard: to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
May 9, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmiss
Hazard: To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to delive
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is t
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is t
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 25, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of t
Hazard: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
April 11, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.via. Medical Device Software. Picture archiving and communications system.
Hazard: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
April 4, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It ca
Hazard: When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
March 28, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated
Hazard: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
March 28, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic i
Hazard: Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
March 21, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following ap
Hazard: The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.via systems with SW VB20A
Hazard: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to genera
Hazard: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generat
Hazard: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Hazard: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 47878
Hazard: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797,
Hazard: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 75
Hazard: Potential for liquid entry
March 7, 2018Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354
Hazard: Potential for liquid entry