Arjo, Inc. dba ArjoHuntleigh: Medical Device Recall in 2017 - (Recall #: Z-2714-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 14, 2017

Date Posted: July 19, 2017

Recall Number: Z-2714-2017

Event ID: 77551

Reason for Recall:

Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

Status: Terminated

Product Quantity: 40,675 units worldwide

Code Information:

Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated