🔍 RecallPedia

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

Class I - Dangerous
🏥 Medical Devices Recalled: September 12, 2013 Convergent Dental Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Convergent Dental
Reason for Recall:
Specific error condition could lead to unintended laser emission during laser activation.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

Product Codes/Lot Numbers:

Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13

Distribution:

Distributed in: US, MA, CT, NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0050-2014

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