FDA recall Z-1535-2018

Heidelberg Engineering · Class II · device

Product

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

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.

Distribution

Nationally

Key facts

Status: Terminated
Initiation date: 2017-12-08
Report date: 2018-05-02
Termination date: 2020-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Franklin, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2018