Recall Z-0205-2018 ยท IRP Massager, Powered Inflatable Tube
Won Industry Co.
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing
| Date | Jan 13, 2017 |
| Status | Terminated |
| Reason | Distribution of unapproved devices with incorrect air compression level setup |
| Root cause | Nonconforming Material/Component |
| Action | Beginning on January 13, 2017, Won Industry Co., Ltd. distributed a Recall Request notices to their customers via email advising customers to retrieve the devices subject to recall. |
| Quantity | 3 |
| Distribution | Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120166 | COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM Won Industrial Co., May 14, 2012 |