Recall Z-0715-2024 ยท LNI System, Nuclear Magnetic Resonance Spectroscopic
Philips North America
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
| Date | Jan 11, 2024 (initiated Jul 15, 2021) |
| Status | Open, Classified |
| Reason | The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.) |
| Root cause | Process change control |
| Action | Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023. Instructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker. |
| Quantity | 56 US; 169 ROW |
| Distribution | Domestic distribution to the following states and territories: CA DE FL GA IL KY MA ME MI MO NH NJ NM NY OH PA SC TN TX VA VT WI WY, and PR. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., May 16, 2022 |