🏥 Medical Devices • 6,554 recalls
Foundation Medicine
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
There were reports of an increase in reactive negative controls and false positive results.
Potential for microbial contamination.
Potential for microbial contamination.
Contec Medical Systems Co.
Patient monitor has nine identified cybersecurity vulnerabilities.
Remote Diagnostic Technologies
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
MEDLINE INDUSTRIES, LP - Northfield
A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Medical device software marketed without FDA clearance .
Siemens Healthcare Diagnostics
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
Medical device software marketed without FDA clearance .
Siemens Healthcare Diagnostics
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
IHB OPERATIONS B.V.
The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Due to manufacturing issues there is a potential for the catheter sheath to detach.
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.