openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
device · product 2 of 2
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
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
