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U.S. Department of Health and Human Services

Class 3 Device Recall Game Ready Professional Therapy System

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  Class 3 Device Recall Game Ready Professional Therapy System see related information
Date Initiated by Firm August 23, 2011
Date Posted September 14, 2011
Recall Status1 Terminated 3 on November 14, 2011
Recall Number Z-3210-2011
Recall Event ID 59826
510(K)Number K071050  
Product Classification Massager, powered inflatable tube - Product Code IRP
Product Game Ready Professional Therapy System,
a cryotherapy device.

Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.
Code Information Model number 550100. Serial numbers: 290617, 217039, 210225, 217061,211091, 217116, 211172, 217422, 211933, 30218115, 212258, 30218182, 214099, 30218591, 214204, 30218660, 215233, 30218661, 215693, 30218712, 216203, 30220291, 216641, 30221427, 216858, 30221743.
Recalling Firm/
Manufacturer		 CoolSystems, Inc.
1201 Marina Village Pkwy
Suite 200
Alameda CA 94501-1087
For Additional Information Contact Marianne Baldwin
510-868-5378
Manufacturer 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.
FDA Determined
Cause 2		 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 President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.
Quantity in Commerce 26 units
Distribution Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.
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 = IRP and Original Applicant = COOLSYSTEMS, INC.
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