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Other Medical Devices

πŸ₯ Medical Devices β€’ 15,809 recalls

ADVIA Centaur XPT Immunoassay System

Siemens Healthcare Diagnostics

Class I - Dangerous

The ADVIA CentaurΒΏ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.

Apr 28, 2016 Other Medical Devices Nationwide View Details β†’

Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.

Aug 17, 2016 Other Medical Devices Nationwide View Details β†’
Class I - Dangerous

For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.

May 30, 2016 Other Medical Devices View Details β†’

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Jul 10, 2016 Other Medical Devices View Details β†’

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Jul 10, 2016 Other Medical Devices View Details β†’

The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.

Aug 24, 2016 Other Medical Devices Nationwide View Details β†’

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.

Aug 1, 2016 Other Medical Devices Nationwide View Details β†’