Philips Expression MR200 MRI Patient Monitoring System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.
  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:
Invivo Corporation
Reason for Recall:
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
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: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.

Distribution:

Distributed in: US, CA, GA, MI, NJ, NV, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0069-2015

Related Recalls

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

Sep 24, 2018 Diagnostic Equipment View Details →