Recall Z-0177-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0177-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-14

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-09-14, terminated 2018-06-26. It names one FDA 510(k) clearance: K033357. Product: Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.. Reason: The firm discovered Ring/Dot artifact due to X-ray measurement error..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Terminated: 2018-06-26
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 Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Reason for recall

The firm discovered Ring/Dot artifact due to X-ray measurement error.

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