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U.S. Department of Health and Human Services

Class 2 Device Recall ArjoHuntleigh Flowtron ACS900

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  Class 2 Device Recall ArjoHuntleigh Flowtron ACS900 see related information
Date Initiated by Firm June 14, 2017
Date Posted June 26, 2017
Recall Status1 Terminated 3 on August 12, 2022
Recall Number Z-2714-2017
Recall Event ID 77551
510(K)Number K143438  
Product Classification Sleeve, limb, compressible - Product Code JOW
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.
Code Information Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.
Recalling Firm/
Manufacturer		 Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison IL 60101-6183
For Additional Information Contact Yvonne McMann
630-307-2756
Manufacturer 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.
FDA Determined
Cause 2		 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 software version V2.000 during the service technician visit. 2. Complete and sign the enclosed Customer Response Form and return this form to the local ArjoHuntleigh office. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices at your facility, free of charge. The device may stay in use until the upgrade will be performed, on the condition that the patients limbs are monitored frequently and the garments are checked to ensure that they are correctly fitted to the patient and that deflation of the garments is occurring on a regular basis. It is also recommended that the pump LCD display is regularly checked to ensure that it shows that the garments are inflating and deflating correctly (in the limited number of complaints, the LCD display was blank). This Field Safety Notice must be distributed to those individuals who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Additionally they should maintain awareness of the notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. The letter states that if the customer has additional questions or they require assistance completing the Customer Response Form, they should contact ArjoHu
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = Getinge (Suzhou) Co., Ltd
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