FDA Enforcement
Class II
Ongoing
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Recall: Z-0477-2022
·
Reported January 19, 2022
Enforcement
- Recall Number
- Z-0477-2022
- 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 A1, 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. 0005, 0023
Distribution
US Nationwide distribution in the states of OH, IN.
Quantity
2 devices quarantined in US