Philips North America Achieva 3.0T, Model No. 781177 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Achieva 3.0T, Model No. 781177
Brand
Philips North America
Lot Codes / Batch Numbers
Model No. 781177 UDI-DI N/A Serial Number 17043
Products Sold
Model No. 781177 UDI-DI N/A Serial Number 17043
Philips North America is recalling Achieva 3.0T, Model No. 781177 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 29, 2023, the firm notified affected customers with URGENT Medical Device Correction letters. The firm stated there is no impact to patients or users. There is a potential risk of electrical shock for service personnel. Customers may continue to use MR systems in accordance with the intended use. Circulate this notice to all users of this device so that they are aware of the issue, and post the letter in the technical room until the electrical shock warning label is updated. A Philips representative will contact you to schedule a time for a Field Service Engineer to verify the electrical shock warning label and apply the correct label if applicable. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026