(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
FDA device recall Z-0715-2024 · posted 2024-01-11 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- Reason for recall
- 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.)
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- LNI
- Quantity affected
- 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.
- Date initiated
- 2021-07-15
- Date posted
- 2024-01-11
- Location
- Cambridge, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583) | Philips Medical Systems Nederland B.V. | 2022-05-16 |