FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-3210-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-08-23
- Posted
- 2011-09-14
- Terminated
- 2011-11-14
- 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 President, Quality Assurance and Regulatory/Clinical Affairs at 510-868-5378.
- Quantity
- 26 units
- Distribution
- Nationwide distribution: CA, MA, MO, NH, OH, TX, UT, and WA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071050"]
- PMA numbers
- not on file
- Product code
- IRP
- Firm FEI
- 3003186150
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28