🔍 RecallPedia

Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986

Class I - Dangerous
🏥 Medical Devices Recalled: August 26, 2019 LivaNova Deutschland GmbH Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    Serial Number: 60S14838 60S14839 60S14829 60S14724 60S14850 60S14858 60S14732 60S14737 60S14844 60S14846 60S14854 60S14855 60S14777 60S14778 60S14725 60S14727 60S14784 60S14785 60S14845 60S14774 60S14775 60S14786 60S14830 60S14776 60S14882
  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:
LivaNova Deutschland GmbH
Reason for Recall:
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986

Product Codes/Lot Numbers:

Serial Number: 60S14838 60S14839 60S14829 60S14724 60S14850 60S14858 60S14732 60S14737 60S14844 60S14846 60S14854 60S14855 60S14777 60S14778 60S14725 60S14727 60S14784 60S14785 60S14845 60S14774 60S14775 60S14786 60S14830 60S14776 60S14882

Distribution:

Distributed in: US, FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2440-2020

Related Recalls

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

LivaNova Deutschland GmbH

Class I - Dangerous

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

Oct 18, 2024 Other Medical Devices Nationwide View Details →