Recall Z-1440-2018— Philips Electronics North America Corporation

Name: FDA recall Z-1440-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-03-16, terminated 2020-04-10. It names one FDA 510(k) clearance: K945945. Product: T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.. Reason: Potential risk for helium gas inside the MR examination room during a magnet quench.

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Terminated: 2020-04-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K945945 — GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NTPhilips Medical Systems North America, Inc.·cleared 1995-12-22

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

T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

Reason for recall

Potential risk for helium gas inside the MR examination room during a magnet quench

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