Recall Z-0402-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0402-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-11

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2017-07-11, terminated 2019-07-02. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems. Reason: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-11
Terminated: 2019-07-02
Firm location: Cleveland, OH, 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

Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

Reason for recall

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

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