Widefield OCT software feature for the Spectralis recall: Software Issue
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Why was Widefield OCT software feature for the Spectralis recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Widefield OCT software feature for the Spectralis HRA+OCT and variants
- Recalling firm
- Heidelberg Engineering
- Quantity
- 382
- Distribution
- Nationally
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)