Arjo, Inc. dba ArjoHuntleigh
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| Z-2714-2017 | Class II | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurren | June 14, 2017 |
| Z-1388-2016 | Class II | The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and ba | December 21, 2015 |
| Z-0079-2015 | Class II | Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky | January 21, 2013 |
| Z-0615-2013 | Class II | Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHunt | December 10, 2012 |
| Z-0476-2013 | Class II | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models | November 16, 2012 |
| Z-0477-2013 | Class II | Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, pat | November 16, 2012 |
| Z-1948-2012 | Class II | Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, | June 29, 2012 |
| Z-1949-2012 | Class II | Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B | June 29, 2012 |
| Z-1947-2012 | Class II | Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, | June 29, 2012 |