FDA-Device2020-03-04Class III
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Maquet Cardiovascular Us Sales, Llc
Hazard
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Sold states
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Affected count
4 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2020Don't want to check this manually?
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