Device recall
Z-0121-2016: Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the…
FDA device recall · Class II · DJO, LLC
Key facts
| Recall number (Z-number) | Z-0121-2016 |
|---|---|
| Recall event | 72168 |
| Product | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues. |
| Product code | IMJ |
| Recalling firm | DJO, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| 510(k) numbers | K083433 |
| FEI number | 2020737 |
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