Reported May 2, 2018 · Terminated
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Heidelberg Engineering
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heidelberg Engineering · 10 Forge Pkwy · Franklin, MA · 02038-3137
Is this the product you have?
- Widefield OCT software feature for the Spectralis HRA+OCT and variants
- Lot codes and dates
- 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.
- Amount recalled
- 382
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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