Other Medical Devices

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

The sterile barrier seal may be compromised.

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

The incorrect device is contained in the package.

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.