Device recall
Z-1782-2021: Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF…
FDA device recall · Class II · CLINICAL LASERTHERMIA SYSTEMS AB
Key facts
| Recall number (Z-number) | Z-1782-2021 |
|---|---|
| Recall event | 87808 |
| Product | Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue. |
| Product code | GEX |
| Recalling firm | CLINICAL LASERTHERMIA SYSTEMS AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2023 |
| 510(k) numbers | K151569, K163103 |
| FEI number | 3012452798 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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