Recall Z-0478-2022— Haag-Streit USA Inc

Name: FDA recall Z-0478-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-03

Class II · Ongoing

Class II FDA medical device recall by Haag-Streit USA Inc, initiated 2021-11-03. It names one FDA 510(k) clearance: K142953. Product: OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4. Reason: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off.

Recalling firm: Haag-Streit USA Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-11-03
Firm location: Mason, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K142953 — OCT-CameraOptomedical Technologies GmbH·cleared 2015-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

Reason for recall

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Data sourced from openFDA. This site is unofficial and independent of the FDA.