Heidelberg Engineering: Medical Device Recall in 2018 - (Recall #: Z-1535-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 8, 2017

Date Posted: May 2, 2018

Recall Number: Z-1535-2018

Event ID: 79453

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.

Status: Terminated

Product Quantity: 382

Code Information:

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.

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated