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.
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
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.
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.
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.
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.
Verify your device runs iOCT-Control 3 v1.4 software by checking the device settings or documentation.
Reach out to Haag-Streit USA for assistance with the recall process or to confirm if your unit is affected.
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.
Check for the OCT-Camera 211 01 A3 model with iOCT-Control 3 v1.4 software and serial numbers 0157, 0158, or 0171.
Contact Haag-Streit USA directly to determine if your unit is affected and to receive guidance on next steps.
We’ve drafted a message you can send Haag-Stre: USA to request your refund or repair — edit it as you like.
Subject: Recall Z-0478-2022 — Haag-Stre: USA Haag-Stre: USA Hello, I own a Haag-Stre: USA that is covered by recall Z-0478-2022 from Haag-Stre: USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
