FDA Enforcement
Class II
Ongoing
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Recall: Z-0478-2022
·
Reported January 19, 2022
Enforcement
- Recall Number
- Z-0478-2022
- Event ID
- 89176
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Haag-Streit USA Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 19, 2022
- Initiation Date
- November 3, 2021
- Classification Date
- January 10, 2022
- Address
- 3535 Kings Mills Rd, N/A, Mason, OH, 45040-2303, United States
Description
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
Code Info
Serial no. 0157, 0158 & 0171
Distribution
US Nationwide distribution in the states of OH, IN.
Quantity
3