FDAFDA · Food and drugs·Recall number Z-0811-2024
Intera 1.5T, Model No. 781195
Published January 31, 2024 · Recall initiated: December 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
- Lot
- Model No. 781195 UDI-DI N/A Serial Number 18887 18972
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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