Recall Z-1805-2025— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2025-05-13. It names 2 FDA 510(k) clearances: K230972, K213516. Product: Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;. 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
510(k) clearances named in this recall
2 on FDA's record- K230972 — Ingenia Elition and MR 7700 MR Systems
- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
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.