Ingenia Ambition X, Model No. 782109

FDA device recall Z-0810-2024 · posted 2024-01-25 · Open, Classified

Recall details

Recalling firm

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.

Action taken

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

Status

Open, Classified

Product code

LNI

Quantity affected

7 US; 16 ROW total

Distribution

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.

Date initiated

2023-12-29

Date posted

2024-01-25

Location

Cambridge, MA

Related 510(k) clearances