Getinge Disinfection Ab
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0016-2026 | Class II | Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | August 29, 2025 |
| Z-1721-2025 | Class II | Washer Disinfector Aquadis 56; Model Number: 56M | April 2, 2025 |
| Z-1720-2025 | Class II | Washer Disinfector Aquadis 56; Model Number: 56A | April 2, 2025 |
| Z-1379-2018 | Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Di | March 2, 2018 |
| Z-1380-2018 | Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07 | March 2, 2018 |
| Z-2419-2015 | Class III | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For | June 26, 2015 |
| Z-0852-2015 | Class II | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series | November 26, 2014 |
| Z-0018-2014 | Class II | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disin | July 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K950566 | DECOMAT 4656 | October 19, 1995 |