May 29, 2024Medical DevicesFDA
Philips North America Llc recalls MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Mode
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. M
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dev
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia 1.5T S Model Number (REF): 781347
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Mode
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0T TX for PET Model Number (REF): 781479
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic d
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Initial system Model Number (REF): 781178
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device M
Hazard: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111
Hazard: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
May 29, 2024Medical DevicesFDA
YAMAHA MOTOR CORPORATION recalls Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Hazard: Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
May 29, 2024Medical DevicesFDA
YAMAHA MOTOR CORPORATION recalls Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, Y
Hazard: Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator, Part Number 1111178
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.