Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Ultradent Products
Class I - Dangerous
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Burlington Medical, Frontal Aprons
Burlington Medical
Class I - Dangerous
Potential for attenuation degradation over time, decreasing the lifespan.
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reflexion Medical
Class I - Dangerous
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Class I - Dangerous
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Burlington Medical, Blockers.
Burlington Medical
Class I - Dangerous
Potential for attenuation degradation over time, decreasing the lifespan.
Class I - Dangerous
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Class I - Dangerous
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Philips S5-2 Ultrasound Transducer
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Corporation of the Americas
Class I - Dangerous
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Philips S4-1 Ultrasound Transducer
Philips Ultrasound
Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
GE Medical Systems
Class I - Dangerous
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.