Medical Device Recall: Washer Disinfector Aquadis 56; Model Number: 56A
Getinge Disinfection Ab · April 2, 2025
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
102 units (8 US, 94 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1720-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.