Recall Z-1535-2018— Heidelberg Engineering
Class II · Terminated
Class II FDA medical device recall by Heidelberg Engineering, initiated 2017-12-08, terminated 2020-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Widefield OCT software feature for the Spectralis HRA+OCT and variants. Reason: 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..
- Recalling firm
- Heidelberg Engineering
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-08
- Terminated
- 2020-06-04
- Firm location
- Franklin, MA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.