Recall Z-2397-2023— Philips North America

Name: FDA recall Z-2397-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-06-12. It names one FDA 510(k) clearance: K213583. Product: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700). 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

1 on FDA's record

K213583 — Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2022-05-16

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

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

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.