Recall Z-0236-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-0236-2015
Creator: U.S. Food and Drug Administration
Published: 2014-07-31

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-07-31, terminated 2017-02-16. It names one FDA 510(k) clearance: K060937. Product: Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the. Reason: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-31
Terminated: 2017-02-16
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060937 — BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc.·cleared 2006-06-05

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

Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

Reason for recall

It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

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