FDAFDA · Food and drugs·Recall number Z-1440-2020
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Published March 11, 2020 · Recall initiated: February 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Invivo Corporation
- Distributor
- U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.
- Lot
- 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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