SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Class I - Dangerous 🏥 Medical Devices
Recalled: July 3, 2019 Heidelberg Engineering GmbH Diagnostic Equipment
Nationwide
What Should You Do?
- Check if you have this product: All software versions with HEYEX2 image management system Identification: TFID-3439
- 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:
- Heidelberg Engineering GmbH
- Reason for Recall:
- Error in the default configuration which could lead to the incorrect display of patient master data.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Product Codes/Lot Numbers:
All software versions with HEYEX2 image management system Identification: TFID-3439
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2437-2019