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Arjo, Inc. dba ArjoHuntleigh recalls ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thro
Recalled July 19, 2017 · FDA recall Z-2714-2017 · Arjo, Inc.
Hazard
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm. · FDA Class II
Units
40,675 units worldwide
Sold at
Worldwide Distribution - US (Nationwide) and internationally to the following countries: United Kingdom, Australia, New Zealand, Japan, Italy, United Arab Emirates, France, Canada, Brazil, Austria, Saudi Arabia, Qatar, India, Switzerland, Bahrain, Kuwait, South Africa, Lebanon, Netherlands, Poland, Spain, Ecuador, Hong-Kong, Colombia, Malaysia, Paraguay, Mauritius, Cyprus, Greece, Oman, Norway, Ireland, Pakistan, Czech Republic, Mexico, Sweden, Tanzania, Hungary, Singapore, Jordan, Israel, Denmark, Chile, and Germany.
Description
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
Product
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.
Manufacturer(s)
Arjo, Inc. dba ArjoHuntleigh
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →