HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01)00884838002791; Serial Numbers: 17362-0001-P through 18057-0266-P
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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.govFDA Recall Number: Z-0603-2019
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