Devices which did not meet internal quality specifications were inadvertently distributed.
Devices which did not meet internal quality specifications were inadvertently distributed.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact 3B Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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React Health PHOENIX 5L Oxygen Concentrator. Reason: Devices which did not meet internal quality specifications were inadvertently distributed.. Classification: Class II. Quantity: 2 units. Distribution: US Nationwide distribution in the state of NY.
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Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility
Labeling: Missing Label
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.