Z-0477-2022 Class II Ongoing
FDA device recall Z-0477-2022 was initiated by Haag-Streit USA Inc on November 3, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 2 devices quarantined in US.
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- November 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices quarantined in US
Product Description
OCT-Camera 211 01 A1, 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
Distribution Pattern
US Nationwide distribution in the states of OH, IN.
Code Information
Serial no. 0005, 0023