OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial no. 0157, 0158 & 0171
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Haag-Streit USA Inc
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Product Codes/Lot Numbers:
Serial no. 0157, 0158 & 0171
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0478-2022
Related Recalls
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Haag-Streit USA
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye