WINGDERM ELECTRO-OPTICS LTD. Recall 95831
Description: Non-ablative Fractional Laser Systems, Model: WFB-01
WINGDERM ELECTRO-OPTICS LTD. Recall 95831 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0555-2025 |
| Event ID | 95831 |
| Event Description | Non-ablative Fractional Laser Systems, Model: WFB-01 |
| Product Type | Devices |
| Distribution | Worldwide Distribution |
| Recall Reason | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units) |
| Device Classification | 20241211 |
| Device Code Info | F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001 |
| Center Classification Date | 20241205 |
| Recall Initiation Date | 20240823 |
| Recalling Firm | WINGDERM ELECTRO-OPTICS LTD. |
| Initial Notification | Letter |
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