Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
La Ciotat Cedex, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Powell, TN, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.
Irvine, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A small number of lenses within the affected lot are of the incorrect power.
West Henrietta, NY, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Trumbull, CT, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Trumbull, CT, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
The proximal thread depth of the spinal device is out of design specification.
Carlsbad, CA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Cambridge, MA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Center Valley, PA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Center Valley, PA, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Versailles, OH, US · Event · Updated
Source: FDA — device enforcement referenceReference notice · device
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Versailles, OH, US · Event · Updated
Source: FDA — device enforcement referenceReport a correction · Related news · Fire information · Clips
