Recall Z-0203-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-0203-2015
Creator: U.S. Food and Drug Administration
Published: 2013-10-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2013-10-23, terminated 2021-03-01. It names one FDA 510(k) clearance: K080927. Product: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.. Reason: It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Terminated: 2021-03-01
Firm location: Andover, MA, 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 XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.

Reason for recall

It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.

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