Haag-Streit OCT-Camera 211 01 A3: Laser shut-off malfunction risk
Haag-Streit USA recalls OCT-Camera 211 01 A3 with iOCT-Control 3 v1.4 software due to potential laser beam shut-off failure. Affected units have serial numbers 0157, 0158, or 0171.
Use caution until it’s fixed
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Contact the company
What happened, in plain English
Haag-Streit USA is recalling OCT-Camera 211 01 A3 models with iOCT-Control 3 v1.4 software because the automatic laser shut-off might not work properly. This could cause the laser to remain active when it should be off, potentially leading to injury. Read more at govinfonow.com/recall/61594-haag-streit-oct-camera-211-01-a3-laser-shut-off.
Source Summary by GovInfoNow · govinfonow.com/recall/61594-haag-streit-oct-camera-211-01-a3-laser-shut-off · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0478-2022
Cite this page
“Haag-Streit OCT-Camera 211 01 A3: Laser shut-off malfunction risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61594-haag-streit-oct-camera-211-01-a3-laser-shut-off. Based on FDA recall #Z-0478-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2022%22&limit=1).
Why it’s dangerous
The camera's automatic laser shut-off mechanism may fail to recognize when the laser beam is safely turned off. This could cause the laser to stay active, potentially exposing users to harmful light levels during eye imaging procedures.
Who’s affected
Users of the OCT-Camera 211 01 A3 with iOCT-Control 3 v1.4 software are affected. Medical professionals using the device for eye imaging are most at risk due to potential laser exposure.
How to tell if you have this one
Check for the OCT-Camera 211 01 A3 model with iOCT-Control 3 v1.4 software. Affected units have serial numbers 0157, 0158, or 0171.
- Brand
Haag-Stre: USA- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of OH, IN.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0477-2022 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4; Serial no. 0005, 0023 | 2 devices quarantined in US |
| Z-0478-2022 | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4; Serial no. 0157, 0158 & 0171 | 3 |
What to do — step by step
Check Software Version
Verify your device runs iOCT-Control 3 v1.4 software by checking the device settings or documentation.
Contact Manufacturer
Reach out to Haag-Streit USA for assistance with the recall process or to confirm if your unit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of OH, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Ohio.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall addresses a potential malfunction where the laser shut-off might not work properly, which could lead to unsafe laser exposure during use. However, the specific risk level is not described as requiring immediate stoppage.
What should I do if I have the affected camera?
Contact Haag-Streit USA directly to determine if your unit is affected and to receive guidance on next steps.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0478-2022 (November 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0478-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.