🔍 RecallPedia

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Class I - Dangerous
🏥 Medical Devices Recalled: July 7, 2022 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
  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:
Olympus Corporation of the Americas
Reason for Recall:
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Product Codes/Lot Numbers:

UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1514-2022

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