Recall Z-2398-2019 ยท QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
OCULOGICA
EyeBOX Model OCL 02
| Date | Apr 16, 2019 |
| Status | Terminated |
| Reason | A review of the user manual revealed that two precaution statements were missing. |
| Root cause | Labeling design |
| Action | IMPORTANT: Warnings and Precautions Correction for the EyeBOX emails were sent to customers on 4/16/19. |
| Quantity | 3 |
| Distribution | The products were distributed to the following US states: MD and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.