FDA-Device2019-06-19Class II
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Maquet Cardiovascular Us Sales, Llc
Hazard
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Sold states
Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
Affected count
4 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1777-2019Don't want to check this manually?
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