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Diagnostic Equipment

🏥 Medical Devices 6,627 recalls

Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.

Jan 14, 2019 Diagnostic Equipment View Details →

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Nov 29, 2018 Diagnostic Equipment Nationwide View Details →

Negative bias results when using VITROS VALP Reagent, GEN 25.

Dec 11, 2018 Diagnostic Equipment Nationwide View Details →

A software update is being issued to correct multiple issues identified in the previous software version.

Dec 19, 2018 Diagnostic Equipment Nationwide View Details →

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

Dec 26, 2018 Diagnostic Equipment Nationwide View Details →

When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.

Dec 20, 2018 Diagnostic Equipment Nationwide View Details →

For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.

Jan 9, 2019 Diagnostic Equipment View Details →

Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

Dec 20, 2018 Diagnostic Equipment Nationwide View Details →