Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1535-2018 — Widefield OCT software feature for the Spectralis HRA+OCT and variants

U.S. FDA — Device Enforcement · United States · 2017-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1535-2018
Date of alert
2017-12-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Heidelberg Engineering
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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