Z-1535-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- December 8, 2017
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 382
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.
Distribution Pattern
Nationally
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.