—#205499

Product

Ingenia Ambition X, Model No. 782109

FDA product code: LNI — System, Nuclear Magnetic Resonance Spectroscopic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K193215
Affected lot / code info: Model No. 782109 UDI-DI 00884838098350 Serial Number 47785

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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).

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

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.

Timeline

Recall initiated: 2023-12-29
Posted by FDA: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.