Recall Z-0391-2024— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2023-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Achieva 1.5T Initial System. Reason: Potential component failure in the Gradient Coil could product smoke and/or fire..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-23
- Firm location
- Cambridge, MA, United States
Product description
Achieva 1.5T Initial System
Reason for recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.