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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.
November 27, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Hazard: SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures
November 20, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326),
Hazard: Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
October 30, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diag
Hazard: An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
September 11, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Mode
Hazard: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and proces
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is intended to generate and proces
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and proces
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and proces
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is intended to generate and proces
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate
Hazard: The injector holder could potentially fall off together with the injector and the storage box.
September 4, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems
Hazard: Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing softwa
Hazard: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software ver
Hazard: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing softwar
Hazard: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software vers
Hazard: The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Hazard: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Hazard: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Hazard: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
August 28, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
Hazard: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process c
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and pr
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and pro
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 21, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and proces
Hazard: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
August 14, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to del
Hazard: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
August 14, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver
Hazard: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
August 14, 2019Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to delive
Hazard: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability