Recall Z-0810-2024 ยท LNI System, Nuclear Magnetic Resonance Spectroscopic
Philips North America
Ingenia Ambition X, Model No. 782109
| Date | Jan 25, 2024 (initiated Dec 29, 2023) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by 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 e |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |