ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA Regulatory Profile
Summary
- Total Recalls
- 9 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0611-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assemble | August 29, 2023 |
| Z-0612-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assemble | August 29, 2023 |
| Z-1098-2022 | Class I | Sara Plus Active Floor Lift | April 5, 2022 |
| Z-2588-2021 | Class II | Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX8 | June 10, 2021 |
| Z-2821-2020 | Class II | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute | July 21, 2020 |
| Z-1452-2020 | Class II | Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 | August 22, 2019 |
| Z-0589-2019 | Class II | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling | October 22, 2018 |
| Z-2718-2016 | Class II | ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care | June 29, 2016 |
| Z-2693-2014 | Class II | Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and tr | July 28, 2014 |