Recall Z-2437-2019 ยท OBO Tomography, Optical Coherence
Heidelberg Engineering GmbH
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | Error in the default configuration which could lead to the incorrect display of patient master data. |
| Root cause | Under Investigation by firm |
| Action | Firm sent field safety notice 7/3/2019. Additionally the customer was asked to let a service technician access their software system to configure it in a way that the software error does not lead to further problems. 1. Do not drag-and-drop patient data onto the automatically created worklist partner as described above. 2. Do not execute a query or retrieve data using the automatically created worklist partner. 3. Always check whether displayed patient master data match the selected patient. In the event that displayed patient master data do not belong to the selected patient, do not cre |
| Quantity | 29 |
| Distribution | US nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH, Sep 13, 2018 |