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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.
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS Q, Interventional Fluroscopic x-ray system
Hazard: In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication Sy
Hazard: Software updates
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Hazard: Software update
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR" Avant-garde
Hazard: Software update
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Mevatron M2/Primus Mid-Energy PRIMUS HI
Hazard: Software update
March 29, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTISTE" MV System
Hazard: Software update
March 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Axiom Artis fluoroscopic x-ray system
Hazard: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
March 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Zee and Zeego fluoroscopic x-ray system
Hazard: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
March 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Q and Q.Zen fluoroscopic x-ray system
Hazard: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRI
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accel
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMU
Hazard: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by
Hazard: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appro
Hazard: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriate
Hazard: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
March 15, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriate
Hazard: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
February 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIM
Hazard: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
February 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Produ
Hazard: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
February 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS
Hazard: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
February 22, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS
Hazard: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
February 8, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is
Hazard: Software error
February 8, 2017Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Syngo.plaza, picture archiving and communications system.
Hazard: Software update for improvements and to resolve several issues
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combine
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are co
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
January 18, 2017Medical DevicesFDA
Siemens Medical Solutions USA Inc. recalls Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are comb
Hazard: Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.