Philips Expression MR200 MRI Patient Monitoring System Model 866120
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
- 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:
- Invivo Corporation
- Reason for Recall:
- During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Product Codes/Lot Numbers:
Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
Distribution:
Distributed in: US, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0001-2015
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