Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Class I - DangerousWhat Should You Do?
- Check if you have this product: 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
- 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:
- Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Product Codes/Lot Numbers:
9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Distribution:
Distributed in: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1440-2020
Related Recalls
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
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
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.