Drug recall
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
FDA recall event 83568 · Class II · Heidelberg Engineering GmbH
Key facts
| Event ID | 83568 |
|---|---|
| Recall numbers | Z-2437-2019 |
| Recalling firm | Heidelberg Engineering GmbH |
| Product type | Devices |
| Products | SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Error in the default configuration which could lead to the incorrect display of patient master data. |
| Initiation date | Jul 3, 2019 |
| Report date | Sep 11, 2019 |
| Termination date | Nov 2, 2020 |
| City | Heidelberg |
| Country | Germany |
| FEI number | 3002807157 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: