Other Medical Devices

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

Potential for units suspended on the ceiling to fail and fall.

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.

Products were stored outside of labeled temperature requirements.

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

Potential for units suspended on the ceiling to fail and fall.

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.