Disinfector, Medical Devices

AMSCO 7052HP Washer/Disinfector

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

AMSCO 7053HP Washer/Disinfector

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

Washer Disinfector Aquadis 56; Model Number: 56A

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

Washer Disinfector Aquadis 56; Model Number: 56M

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.

Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying

Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipmen

Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.

Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusabl

Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements.

Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.