Recall Z-0919-2019— Philips Medical Systems Nederlands

Name: FDA recall Z-0919-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-12-21, terminated 2020-11-19. It names one FDA 510(k) clearance: K163116. Product: Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System. Reason: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field..

Recalling firm: Philips Medical Systems Nederlands
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Terminated: 2020-11-19
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K163116 — Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V.·cleared 2017-01-06

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 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Data sourced from openFDA. This site is unofficial and independent of the FDA.