Other Medical Devices

Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

Software update

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

System locks up which may result in potential patient injury or delay in diagnosis or treatment.

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.

Incorrect priming volume printed on the device package.

Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

Software update

Labeling error

ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Software update

Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

Incorrect instructions for use (IFU) included.