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Getinge Disinfection Ab recalls Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Ge
Recalled April 25, 2018 · FDA recall Z-1380-2018 · Getinge Disinfection Ab
Hazard
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment. · FDA Class II
Units
170 total products
Sold at
Worldwide Distribution - USA (nationwide) and the following countries: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, NETHERLANDS, NORWAY, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NORWAY, NEW ZELAND, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVENIA, THAILAND
Description
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
Product
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
Manufacturer(s)
Getinge Disinfection Ab
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →