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To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Devices which did not undergo thermoforming could deform and lose performance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Devices which did not undergo thermoforming could deform and lose performance.

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Devices which did not undergo thermoforming could deform and lose performance.

Devices which did not undergo thermoforming could deform and lose performance.

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There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Devices which did not undergo thermoforming could deform and lose performance.

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Devices which did not undergo thermoforming could deform and lose performance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

Devices which did not undergo thermoforming could deform and lose performance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Devices which did not undergo thermoforming could deform and lose performance.

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Devices which did not undergo thermoforming could deform and lose performance.