Getinge Disinfection Ab: Device Recall

Recall Details

Recall Number

Z-1721-2025

Classification

Class II

Product Type

Device

Recalling Firm

Getinge Disinfection Ab

Status

Ongoing

Date Initiated

04/02/2025

Location

Vaxjo, N/A, Sweden

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

424 units (79 US, 345 OUS)

Reason for Recall

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.

Product Description

Washer Disinfector Aquadis 56; Model Number: 56M

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Kenya, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Vietnam, Zambia.

Other Recalls by Getinge Disinfection Ab

• Class II: Risk 08/29/2025
  Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
• Class II: Risk 04/02/2025
  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.

View all recalls by Getinge Disinfection Ab →