Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42023, 42024, 42078, 42375, 42402, 42408, 71348, 85675, 85687, 85694, 85705, (2) 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85684, 85688, 85690, 85695, 85697, 85699, 85708;
- 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:
- Philips North America Llc
- Reason for Recall:
- Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Product Codes/Lot Numbers:
Model Numbers: (1) 782117, (2) 782143; UDI-DI: (1) 00884838099739, (2) 00884838108660; Serial Numbers: (1) 42023, 42024, 42078, 42375, 42402, 42408, 71348, 85675, 85687, 85694, 85705, (2) 42193, 42225, 42308, 42320, 42366, 42415, 71595, 71815, 71836, 85649, 85684, 85688, 85690, 85695, 85697, 85699, 85708;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1794-2025
Related Recalls
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
IntelliVue MP90. Product Number: M8010A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue MP30. Product Number: M8002A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.