Reported Jan 2, 2013 · Terminated

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

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • 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.
Lot codes and dates
  • 274 of 274 codes

    • Model #728260
    • Serial #s
    • 12876
    • 13924
    • 13994
    • 13996
    • 14104
    • 14116
    • 14677
    • 14682
    • 14694
    • 14695
    • 14702
    • 14707
    • 14710
    • 14727
    • 14728
    • 14730
    • 14824
    • 14840
    • 14926
    • 14930
    • 14932
    • 14940
    • 15008
    • 15015
    • 15017
    • 15023
    • 15036
    • 15081
    • 15085
    • 15146
    • 15329
    • 15354
    • 15393
    • 15397
    • 15398
    • 15399
    • 15400
    • 15401
    • 15402
    • 15403
    • 15451
    • 15453
    • 15550
    • 15551
    • 15552
    • 15553
    • 15554
    • 15555
    • 15556
    • 15557
    • 15558
    • 15559
    • 15560
    • 15561
    • 15562
    • 15563
    • 15564
    • 15565
Amount recalled
265 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 24, 2013 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.