FDA-Device2025-10-08Class II
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Getinge Disinfection Ab
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.
Affected count
902 units
Manufactured in
Ljungadalsgatan 11, N/A, Vaxjo, N/A, Sweden
Products
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2026Don't want to check this manually?
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