Arjo Hospital Equipment AB
FDA Regulatory Profile
Arjo Hospital Equipment AB appears in FDA public data with 5 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1217-2015, Class II) was initiated on December 3, 2014. Its most recent 510(k) clearance was granted on April 8, 2009.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1217-2015 | Class II | Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the | December 3, 2014 |
| Z-1218-2015 | Class II | TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy Syste | December 3, 2014 |
| Z-1216-2015 | Class II | RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers | December 3, 2014 |
| Z-1247-2015 | Class II | Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with | September 1, 2014 |
| Z-0019-2015 | Class II | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs | March 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082951 | IMMERSION HYDROBATH | April 8, 2009 |