Devices

Device Recall Widefield OCT software

Model / Serial
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 Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Nationally
Product Description
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Manufacturer
Heidelberg Engineering
1 Event
- Recall of Device Recall Widefield OCT software

Manufacturer

Heidelberg Engineering

Manufacturer Address
Heidelberg Engineering, 10 Forge Pkwy, Franklin MA 02038-3137
Manufacturer Parent Company (2017)
Heidelberg Engineering Inc.
Source
USFDA

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