Ingenia 1.5T CX
Philips North America
Class I - Dangerous
Potential component failure in the Gradient Coil could product smoke and/or fire.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
LEONI CIA CABLE SYSTEMS
Class I - Dangerous
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
Achieva 1.5T
Philips North America
Class I - Dangerous
Potential component failure in the Gradient Coil could product smoke and/or fire.
Class I - Dangerous
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Class I - Dangerous
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class I - Dangerous
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Achieva 1.5T Initial System
Philips North America
Class I - Dangerous
Potential component failure in the Gradient Coil could product smoke and/or fire.
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Aizu Olympus Co.
Class I - Dangerous
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
VariSoft infusion set, Model Number 1002827
Unomedical A/S
Class I - Dangerous
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Achieva 1.5T Conversion
Philips North America
Class I - Dangerous
Potential component failure in the Gradient Coil could product smoke and/or fire.
Class I - Dangerous
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
LEONI CIA CABLE SYSTEMS
Class I - Dangerous
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Class I - Dangerous
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection