Recall Z-0479-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0479-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-09-28, terminated 2013-12-24. It names one FDA 510(k) clearance: K961464. Product: Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.. Reason: Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Terminated: 2013-12-24
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K961464 — SELECT/SPElscint, Inc.·cleared 1996-07-03

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

Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Reason for recall

Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.

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