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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 Systemsee related information
Date Initiated by FirmAugust 23, 2011
Date PostedSeptember 14, 2011
Recall Status1 Terminated 3 on November 14, 2011
Recall NumberZ-3210-2011
Recall Event ID 59826
510(K)NumberK071050 
Product Classification Massager, powered inflatable tube - Product Code IRP
ProductGame 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.
FEI Number 3003186150
Recalling Firm/
Manufacturer		 CoolSystems, Inc.
1201 Marina Village Pkwy
Suite 200
Alameda CA 94501-1087
For Additional Information ContactMarianne 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
ActionThe 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 Commerce26 units
DistributionNationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IRP
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