Recall Z-2414-2021— Philips North America Llc

Name: FDA recall Z-2414-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-11

Class II · Completed

Class II FDA medical device recall by Philips North America Llc, initiated 2021-08-11. It names one FDA 510(k) clearance: K162931. Product: Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262. Reason: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Completed
Initiated: 2021-08-11
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX 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 CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262

Reason for recall

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

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