FDA Device recall Z-2437-2019
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device by Heidelberg Engineering, citing error in the default configuration which could lead to the incorrect display of patient master data.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2437-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Heidelberg Engineering |
| Distribution | US |
Product
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Reason
Error in the default configuration which could lead to the incorrect display of patient master data.
Identifiers
| code_info | All software versions with HEYEX2 image management system Identification: TFID-3439 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2437-2019%22
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