Recall Z-0593-2017— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0593-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-13

Class III · Terminated

Class III FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-10-13, terminated 2018-06-29. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT Computed Tomography X-ray system, Model 728306. Reason: The product label does not include the correct current rating..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class III
Status: Terminated
Initiated: 2016-10-13
Terminated: 2018-06-29
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 Computed Tomography X-ray system, Model 728306

Reason for recall

The product label does not include the correct current rating.

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