Haag-Streit USA recalls OCT-Camera 211 01 A1 with iOCT-Control 3 v1.4 software due to potential laser beam shut-off malfunction. Affected units may not detect safe laser shutdown, risking injury during use.
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 A1 models with iOCT-Control 3 v1.4 software because the laser beam shut-off system might not work properly. This could cause the camera to fail to recognize when the laser is safely turned off, potentially leading to injury.
The camera's automatic laser beam shut-off system may malfunction, causing it to fail in recognizing when the laser beam is safely switched off. This could lead to unintended laser exposure during use, especially in medical procedures involving eye imaging.
Users of the OCT-Camera 211 01 A1 with iOCT-Control 3 v1.4 software are affected. Medical professionals using this device for eye imaging are most at risk due to potential laser exposure.
Check for the OCT-Camera 211 01 A1 model with iOCT-Control 3 v1.4 software. Affected units have serial numbers 0005 or 0023.
Verify your OCT-Camera 211 01 A1 is running iOCT-Control 3 v1.4 software.
Reach out to Haag-Streit USA for guidance on next steps.
The recall addresses a potential malfunction where the camera might not detect when the laser beam is safely switched off, which could lead to injury during use. However, the remedy does not specify immediate action to stop use.
Your OCT-Camera 211 01 A1 with iOCT-Control 3 v1.4 software and serial numbers 0005 or 0023 are affected.
The recall does not provide specific action steps beyond checking software version and contacting Haag-Streit USA for guidance.
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-0477-2022 — Haag-Stre: USA Haag-Stre: USA Hello, I own a Haag-Stre: USA that is covered by recall Z-0477-2022 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.
