Recall Z-1794-2025— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2025-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;. Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-13
- Firm location
- Cambridge, MA, United States
Product description
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Reason for recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Data sourced from openFDA. This site is unofficial and independent of the FDA.