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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77551

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 14, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arjo, Inc. dba ArjoHuntleigh

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2714-2017
Recall number
Z-2714-2017
Initiated
June 14, 2017
Classification
Class II
Status
Terminated
Quantity
40,675 units worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.