🔍 RecallPedia

HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

Class I - Dangerous
🏥 Medical Devices Recalled: November 23, 2018 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
  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:
Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

Product Codes/Lot Numbers:

UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0603-2019

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