Device product
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Z-0477-2022
Product summary
- Event
- Event 89176
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 devices quarantined in US
- Official record key
device-enforcement:Z-0477-2022
Official wording
Reason: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Code information: Serial no. 0005, 0023
Distribution pattern: US Nationwide distribution in the states of OH, IN.
Derived failure modes
-
Unknown
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off