🔍 RecallPedia

Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

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: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708
  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 - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

Product Codes/Lot Numbers:

Serial Number: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708

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-2439-2020

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 →