Recall Z-2714-2017 ยท JOW Sleeve, Limb, Compressible
Arjo, Inc. dba ArjoHuntleigh
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 healt
| Date | Jun 26, 2017 (initiated Jun 14, 2017) |
| Status | Terminated |
| Reason | Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm. |
| Root cause | Under Investigation by firm |
| Action | ArjoHuntleigh sent a Field Safety Notice and Customer Response form to affected customers describing the reason for the recall and the actions to be taken. The instruction to customers is to review the Field Safety Notice and complete the Customer Response Form to acknowledge receipt and understanding of the Field Safety Notice and the required actions. These actions taken are as follows: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this Field Safety Notice (FSN) and all listed devices at facility are available to be upgraded to softwa |
| Quantity | 40,675 units worldwide |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143438 | Flowtron ACS900 Getinge (Suzhou) Co., Ltd., Jun 23, 2015 |