Achieva 1.5T, Model No. 781178, 781196, 781296
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388
- 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
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Achieva 1.5T, Model No. 781178, 781196, 781296
Product Codes/Lot Numbers:
Model No. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0807-2024
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.