Z-2437-2019Class II

SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device

Name: Z-2437-2019 SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device
Creator: Heidelberg Engineering GmbH
Published: 2019-07-03
License: https://open.fda.gov/license/

Heidelberg Engineering GmbH / initiated 2019-07-03 / Terminated

FDA source

Heidelberg Engineering GmbH began a recall of SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device on 2019-07-03. FDA classified it as Class II and gives the reason as "Error in the default configuration which could lead to the incorrect display of patient master data". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2437-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2019-08-30
Terminated: 2020-11-02
Recalling firm: Heidelberg Engineering GmbH
Product: SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Product code: OBO Tomography, Optical Coherence
Reason for recall: Error in the default configuration which could lead to the incorrect display of patient master data.
FDA 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 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 [email protected].
Quantity in commerce: 29
Distribution: US nationwide distribution
Product codes and lots: All software versions with HEYEX2 image management system Identification: TFID-3439

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2437-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2437-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code OBO

K181594Class IISpectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH / cleared 2018-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)