Recall Z-1380-2018— Getinge Disinfection Ab
Class II · Terminated
Class II FDA medical device recall by Getinge Disinfection Ab, initiated 2018-03-02, terminated 2022-05-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Getinge Disinfection Ab
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-02
- Terminated
- 2022-05-13
- Firm location
- Vaxjo, Sweden
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.