Recall Z-1500-2017 ยท NFJ System, Image Management, Ophthalmic
Haag-Streit USA Inc
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
| Date | Jan 5, 2017 |
| Status | Terminated |
| Reason | There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. |
| Root cause | Software design |
| Action | On January 5, 2017 the firm sent Field Safety Notice to their customers. |
| Quantity | 163 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142423 | EyeSuite Imaging Haag-Streit AG, Sep 10, 2014 |