OCT-Camera 211 01 A1 — Class II medical device recall Z-0477-2022
Ongoing recall by Haag-Streit USA Inc, reported 2022-01-19, distributed nationwide. Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is s
| Recall number | Z-0477-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haag-Streit USA Inc, Mason, OH, United States |
| Recall initiated | 2021-11-03 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 2 devices |
| Reason classes | device malfunction |
| Serial numbers | 0005, 0023 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0477-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.