Heidelberg Engineering Recalls Widefield OCT Software Feature for Spectralis Devices
Heidelberg Engineering is recalling the Widefield OCT software feature for Spectralis HRA+OCT devices because FDA determined a 510(k) clearance is required before use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a regulatory compliance recall (missing 510(k) clearance) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Heidelberg Engineering is recalling the Widefield OCT software feature for the Spectralis HRA+OCT and variants. The recall involves 382 units distributed nationally. The software feature was available on SPECTRALIS Software US versions 6.3 to 6.8a and requires the Widefield Objective Module accessory and a dedicated license to operate.
The recall was initiated after the U.S. Food and Drug Administration notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature. On November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked the company to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained.
Customers who have the Widefield OCT software feature should stop using it immediately and contact Heidelberg Engineering for further instructions regarding the pending clearance.
The recalled product
- Product
- Widefield OCT software feature for the Spectralis HRA+OCT and variants
- Manufacturer
- Heidelberg Engineering
- Affected units
- 382
Distribution
Distribution scope not specified by the agency.
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