OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Reported: January 19, 2022 Initiated: November 3, 2021 #Z-0478-2022
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
Details
- Recalling Firm
- Haag-Streit USA Inc
- Units Affected
- 3
- Distribution
- US Nationwide distribution in the states of OH, IN.
- Location
- Mason, OH
Frequently Asked Questions
What product was recalled? ▼
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4. Recalled by Haag-Streit USA Inc. Units affected: 3.
Why was this product recalled? ▼
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0478-2022.
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