🔍 RecallPedia

Draeger Infinity Acute Care System Monitoring Solution

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2013 Draeger Medical Systems Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    with software versions VG2.0.3 and higher.
  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:
Draeger Medical Systems, Inc.
Reason for Recall:
After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Draeger Infinity Acute Care System Monitoring Solution

Product Codes/Lot Numbers:

with software versions VG2.0.3 and higher.

Distribution:

Distributed in: US, MA, NH, IN, CA, TX, NY, OK, IL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0714-2014

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