FDA Device recall Z-1379-2018
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 0734015370025…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 0734015370025… by Getinge Disinfection Ab, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1379-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-02 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Getinge Disinfection Ab |
| Distribution | US |
Product
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 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.
Identifiers
| code_info | UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Serial Number…UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Serial Numbers: WAA075345 WAA059630 WAA060690 WAA061680 WAA062179 WAA062399 WAA062743 WAA062967 WAA064062 WAA064977 WAA071262 WAA076435 WAA078694 WAA080011 WAA080693 WAA070436 WAA080985 WAA61348 WAA61349 WAA058540 WAA058542 WAA058543 WAA058545 WAA059053 WAA059054 WAA061345 WAA061346 WAA061347 WAA061350 WAA061351 WAA061353 WAA062020 WAA062021 WAA062022 WAA062360 WAA062361 WAA062362 WAA062363 WAA062364 WAA062365 WAA063372 WAA063373 WAA063374 WAA069593 WAA074456 WAA063375 WAA081641 WAA081811 WAA081883 WAA081884 WAA083599 WAA062023 WAA066165 WAA066166 WAA066167 WAA066168 WAA056686 WAA057547 WAA058549 WAA058550 WAA058551 WAA058552 WAA058553 WAA058554 WAA059058 WAA059059 WAA060871 WAA060886 WAA060887 WAA060888 WAA060889 WAA060926 WAA060927 WAA060928 WAA060930 WAA061284 WAA061285 WAA061286 WAA061287 WAA061288 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1379-2018%22
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