Recall Z-1011-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1011-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-12

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-11-12, terminated 2018-07-02. It names one FDA 510(k) clearance: K080927. Product: BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging. Reason: Unintended detector and gantry movement due to software issues..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-12
Terminated: 2018-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K080927 — BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-11

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

BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

Reason for recall

Unintended detector and gantry movement due to software issues.

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