Device product
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Z-2437-2019
Product summary
- Event
- Event 83568
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-2437-2019
Official wording
Reason: Error in the default configuration which could lead to the incorrect display of patient master data.
Code information: All software versions with HEYEX2 image management system Identification: TFID-3439
Distribution pattern: US nationwide distribution
Derived failure modes
-
Unknown
Error in the default configuration which could lead to the incorrect display of patient master data.