Recall Z-2404-2012— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2404-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-28

Class III · Terminated

Class III FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-08-28, terminated 2013-12-24. It names one FDA 510(k) clearance: K012009. Product: The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.. Reason: Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class III
Status: Terminated
Initiated: 2012-08-28
Terminated: 2013-12-24
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K012009 — MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc.·cleared 2001-09-13

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

The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Reason for recall

Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.

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