Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU).
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Philips Medical Systems (Cleveland)
Class I - Dangerous
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Ingenuity TF PET/CT. Diagnostic imaging system
Philips Medical Systems (Cleveland)
Class I - Dangerous
The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.
Class I - Dangerous
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
Class I - Dangerous
Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity
Class I - Dangerous
Sterility of device may be compromised due to lack of package integrity