Recall Z-3210-2011 ยท IRP Massager, Powered Inflatable Tube
CoolSystems, Inc.
Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.
| Date | Sep 14, 2011 (initiated Aug 23, 2011) |
| Status | Terminated |
| Reason | It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped. |
| Root cause | Employee error |
| Action | The firm, CoolSystems, Inc., contacted customers by phone on August 23, 2011. The customers were informed that some Game Ready Professional Therapy System units have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory and shipped. Instructions were given to immediately cease fulfilling orders from that inventory. Loaners were shipped to the customers overnight. The customers were instructed to replace the shipped device with the loaner that was sent and return it to the company ASAP. If you have any questions, contact the Vice Preside |
| Quantity | 26 units |
| Distribution | Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071050 | GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM Coolsystems, Inc., Jun 29, 2007 |