Heidelberg Engineering GmbH Tiergartenstr. 15 Heidelberg Germany SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Error in the default configuration which could lead to the incorrect display of patient master data.

Recommended Action

Per FDA guidance

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 create any new reports or screen shots of data for the affected patient. In this case, check already exported reports of this patient and correct the data manually or discard them if necessary. 4. A service technician will contact you to correct the configuration. This configuration correction will be performed remotely via a simple update. At the same time, the technician will also confirm the integrity of your database, ensuring that it is free of inconsistencies. If you have any question or concern, please contact FSCA-US@HeidelbergEngineering.com.