🔍 RecallPedia

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

Class I - Dangerous
🏥 Medical Devices Recalled: February 9, 2021 Philips North America Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514
  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:
Customers were not notified of previous recalls associated with various defibrillator models.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

Product Codes/Lot Numbers:

Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

Distribution:

Distributed in: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0078-2022

Related Recalls