Recall Z-2382-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2382-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-29

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-04-29, terminated 2018-07-02. It names one FDA 510(k) clearance: K060937. Product: Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.. Reason: Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-29
Terminated: 2018-07-02
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 No. 728311; To produce cross-sectional images of the body.

Reason for recall

Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.

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