🔍 RecallPedia

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

Class I - Dangerous
🏥 Medical Devices Recalled: May 15, 2020 Mediana Co. Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 456802000001~456802000180
  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:
Mediana Co., Ltd.
Reason for Recall:
Failures were found in the temperature measurement function while in the predict mode.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

Product Codes/Lot Numbers:

Serial Numbers: 456802000001~456802000180

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2441-2020

Related Recalls