FDA Medical Device Recalls (openFDA)
Heidelberg Engineering GmbH: SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Recall number
- Z-2437-2019
- Recalling firm
- Heidelberg Engineering GmbH
- Product
- SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
- Status
- Terminated
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- 2020-11-02
- Reason
- Error in the default configuration which could lead to the incorrect display of patient master data.
- 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 FSCA-US@HeidelbergEngineering.com.
- Quantity
- 29
- Distribution
- US nationwide distribution
- Lot, serial or model codes
- All software versions with HEYEX2 image management system Identification: TFID-3439
- 510(k) numbers
- ["K181594"]
- PMA numbers
- not on file
- Product code
- OBO
- Firm FEI
- 3002807157
- Firm city
- Heidelberg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28