FDA Device recall Z-0477-2022
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
- FDA Device
- Class II
- ongoing
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 by Haag Streit Usa, citing malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0477-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-03 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Haag Streit Usa |
| Distribution | US |
Product
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
Identifiers
| code_info | Serial no. 0005, 0023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0477-2022%22
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