Achieva 3.0T, Model No. 781177
FDA Recall Z-0809-2024 · Posted 2024-01-25
Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeLNI
Date Initiated2023-12-29
Product Quantity7 US; 16 ROW total
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.
Firm Action
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).
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.