Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduc
FDA device recall Z-3210-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- CoolSystems, Inc.
- Reason for recall
- 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.
- Action taken
- 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 President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- IRP
- Quantity affected
- 26 units
- Distribution
- Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.
- Date initiated
- 2011-08-23
- Date posted
- 2011-09-14
- Date terminated
- 2011-11-14
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM (K071050) | Coolsystems, Inc. | 2007-06-29 |