Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Height

FDA device recall Z-0479-2013 · posted 2012-12-21 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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.

Action taken

Philips sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips is issuing a system update to all of the Extended Brilliance Workspace (EBW) systems currently running software version 4.5.4. The update will provide a number of improvements to the overall quality and functionality of the EBW systems. If you need further information or support concerning this issue, please contact your local Philips representative. In the United States and Canada, please call the Philips Healthcare Customer Care Solutions Center at 1-800-722-9377, and follow the recorded menu options to reach a Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.

Root cause

Software design

Status

Terminated

Product code

KPS

Quantity affected

265 units

Distribution

Worldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India

Date initiated

2012-09-28

Date posted

2012-12-21

Date terminated

2013-12-24

Location

Cleveland, OH

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