Device recall
Z-3210-2011: Game Ready Professional Therapy System, a cryotherapy device. Intended to treat…
FDA device recall · Class III · CoolSystems, Inc.
Key facts
| Recall number (Z-number) | Z-3210-2011 |
|---|---|
| Recall event | 59826 |
| 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 |
| Recalling firm | CoolSystems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 14, 2011 |
| 510(k) numbers | K071050 |
| FEI number | 3003186150 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database