Other Medical Devices

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.

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.

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

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

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.

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

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

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

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

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.

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.

BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.