Recall Z-0519-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0519-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-06

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2017-10-06, terminated 2019-07-02. It names one FDA 510(k) clearance: K160743. Product: Philips Ingenuity Core computed tomography x-ray system. Reason: Numerous issues related to software Brilliance iCT 4.1.6 software version..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Terminated: 2019-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K160743 — Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc.·cleared 2016-08-08

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 Ingenuity Core computed tomography x-ray system

Reason for recall

Numerous issues related to software Brilliance iCT 4.1.6 software version.

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