🔍 RecallPedia

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: August 19, 2019 Intuitive Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
  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:
Intuitive Surgical, Inc.
Reason for Recall:
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Product Codes/Lot Numbers:

Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2131-2020

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