Recall Z-2396-2023— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2023-06-12. It names 5 FDA 510(k) clearances: K213516, K193215, K183063 and 2 more. Product: Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106. Reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-12
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K173451 — Ingenia Elition S and Ingenia Elition X
- K173356 — Ingenia Elition S and Ingenia Elition X R5.4
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
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Reason for recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.