Arjo, Inc. dba ArjoHuntleigh

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2714-2017Class IIArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrenJune 14, 2017
Z-1388-2016Class IIThe Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and baDecember 21, 2015
Z-0079-2015Class IIMedium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky January 21, 2013
Z-0615-2013Class IIFlowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntDecember 10, 2012
Z-0476-2013Class IIEnterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models November 16, 2012
Z-0477-2013Class IIEnterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patNovember 16, 2012
Z-1948-2012Class IIChorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, June 29, 2012
Z-1949-2012Class IISara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, BJune 29, 2012
Z-1947-2012Class IIEncore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, June 29, 2012