Philips Expression MR200 MRI Patient Monitoring System.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.
- 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:
- The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
- 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.
Product Codes/Lot Numbers:
Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.
Distribution:
Distributed in: CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0958-2015
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