Z-1535-2018Class II

Widefield OCT software feature for the Spectralis HRA+OCT and variants

Name: Z-1535-2018 Widefield OCT software feature for the Spectralis HRA+OCT and variants
Creator: Heidelberg Engineering
Published: 2017-12-08
License: https://open.fda.gov/license/

Heidelberg Engineering GmbH / initiated 2017-12-08 / Terminated / root cause: software

FDA source

Heidelberg Engineering began a recall of Widefield OCT software feature for the Spectralis HRA+OCT and variants on 2017-12-08. FDA classified it as Class II and gives the reason as "FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1535-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Posted: 2018-04-26
Terminated: 2020-06-04
Recalling firm: Heidelberg Engineering GmbH
Product: Widefield OCT software feature for the Spectralis HRA+OCT and variants
Product code: OBO Tomography, Optical Coherence
Reason for recall: FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
Root cause tag: software
FDA root cause: No Marketing Application
Action: On December 14, 2017 an URGENT Medical device software field correction letter was issued to customers via email or ground mail to notify all customers of the recall action. The letter states the following: FDA has asked us to instruct you not to use the Widefield OCT feature on your SPECTRALIS device until a decision is made on this pending 510(k) submission. Heidelberg Engineering will notify you immediately upon completion of the FDAs review. In the meantime, you may continue to use your Widefield Objective for cSLO fundus imaging (including Fluorescein Angiography, ICG Angiography, MultiColor, Infrared and Red-Free Fundus Imaging). Questions or concerns can be directed to (508) 530-5904
Quantity in commerce: 382
Distribution: Nationally
Product codes and lots: The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a It is only usable with the Widefield Objective Module accessory and a dedicated license.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1535-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code OBO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)