🔍 RecallPedia

da Vinci SP surgical system

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2019 Intuitive Surgical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
  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:
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

da Vinci SP surgical system

Product Codes/Lot Numbers:

Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030

Distribution:

Distributed in: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2260-2020

Related Recalls