Z-3210-2011

Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute...

Name: Z-3210-2011 Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute...
Creator: CoolSystems, Inc.
Published: 2011-08-23
License: https://open.fda.gov/license/

Coolsystems, Inc. / initiated 2011-08-23 / Terminated / root cause: manufacturing process

FDA source

CoolSystems, Inc. began a recall of Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where... on 2011-08-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3210-2011
Status: Terminated
Initiated: 2011-08-23
Posted: 2011-09-14
Terminated: 2011-11-14
Recalling firm: Coolsystems, Inc.
Product: Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.
Product code: IRP Massager, Powered Inflatable Tube
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Product code IRP

K071050Class IIGame Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy SystemCoolsystems, Inc. / cleared 2007-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)