Getinge Disinfection AB
VAXJO Kronoberg, SE
GETINGE DISINFECTION AB appears in FDA device records in VAXJO Kronoberg, SE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Getinge Disinfection AB in 1995.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616031 | 3000231474 | GETINGE DISINFECTION AB | LJUNGADALSGATAN 11, VAXJO Kronoberg 352 46 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0016-2026 | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. | Class II | Open, Classified | |
| Z-1721-2025 | Washer Disinfector Aquadis 56; Model Number: 56M | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing. | Class II | Open, Classified | |
| Z-1720-2025 | Washer Disinfector Aquadis 56; Model Number: 56A | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing. | Class II | Open, Classified | |
| Z-1380-2018 | 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. | Class II | Terminated | |
| Z-1379-2018 | 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. | Class II | Terminated | |
| Z-2419-2015 | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. | Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. | Class III | Terminated | |
| Z-0852-2015 | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. | Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur. | Class II | Terminated | |
| Z-0018-2014 | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. | Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain