Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
191 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Philips Medical Systems Nederland, 2022-IGT-BST-012, SmartPerfusion OWB, 2D Perfusion OWB
Philips has identified through an internal investigation that SmartPerfusion and 2D Perfusion have technical issues related to ...
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Remote Diagnostic Technologies, 2022-CC-EC-017, Tempus Pro Patient Monitor
However, testing revealed that the device does not meet the standards for Fluid and Particulate lngress.
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Respironics LLC, 2022-CC-HRC-013, V680 Ventilator
The purpose of this letter is to communicate a market removal over the next six months of the Philips Respironics V680 (V680) ...
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Philips Medical Systems, FSCA 2021-CC-EC-012-IR, Infant.Child SMART Pads Cartridge, Adult SMART Pads Cartridge, Used with the HS1 Home and Onsite Defibrillators
Het is voorgekomen dat de gel van sommige elektroden die worden gebruikt voor de HS1/OnSite/Home-AED loskomt van de ...
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Bolton Medical Inc, 2247858-12-06-2022-001R, RelayPro Thoracic Stent Graft System
The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...
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Philips Goldway Shenzhen Industrial Inc., 2021-CC-EC-023-IR, Efficia External Paddles
The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...
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Philips Goldway Shenzhen Industrial Inc., 2022-CC-EC-010-IR, Efficia Pads Adapter Cable
Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators are at risk of failed ECG monitoring, defibrillation, synchronized ...
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Clinical Innovations LLC, FSCA 2022-CC-HPM-061, Fetal Measurements
Philips has become aware of a potential safety issue with the Fetal Spiral Electrode (FSE) based on complaints related to the ...
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Philips Medical Systems, FSCA 2022-CC-HPM-051, MR Patient Care Portal 5000
During manufacturing inspection of the MR Patient Care Portal 5000, it was discovered that two (2) Portal 5000 units would ...
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Philips Respironics, 2022-CC-SRC-001, Amara View Minimal Contact Full-Face Mask (Full Face Mask) DreamWear Full Face Mask (Full Face Mask) DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask) Wisp Nasal Mask (Nasal Mask) Wisp You
Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the ...