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

Class I - Dangerous

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

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The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details β†’