🔍 RecallPedia

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

Class I - Dangerous
🏥 Medical Devices Recalled: August 31, 2023 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
  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:
Philips North America Llc
Reason for Recall:
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

Product Codes/Lot Numbers:

UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2654-2023

Related Recalls