Recall Z-2368-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2368-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-24

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-03-24, terminated 2018-07-02. It names one FDA 510(k) clearance: K033357. Product: Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.. Reason: Software defect causing intermittently slow response of Host..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Terminated: 2018-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc.·cleared 2004-01-09

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 BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Reason for recall

Software defect causing intermittently slow response of Host.

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