Reported Mar 13, 2013 · Terminated

Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance…

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?

  • Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Lot codes and dates
  • 2,684 of 2,684 codes

    • Model 728260
    • Serial #
    • 3467
    • 5610
    • 6151
    • 6204
    • 6209
    • 6221
    • 6437
    • 6483
    • 6543
    • 6636
    • 6658
    • 6717
    • 6788
    • 6865
    • 7154
    • 7186
    • 7253
    • 7470
    • 7507
    • 7576
    • 7579
    • 7639
    • 7690
    • 7692
    • 7708
    • 7835
    • 7977
    • 8099
    • 8255
    • 8332
    • 8443
    • 8756
    • 8757
    • 8890
    • 8922
    • 9079
    • 9201
    • 9395
    • 9422
    • 10085
    • 10086
    • 10090
    • 10102
    • 10138
    • 10155
    • 10180
    • 10197
    • 10216
    • 10240
    • 10261
    • 10264
    • 10271
    • 10312
    • 10324
    • 10328
    • 10346
    • 10355
    • 10359
Amount recalled
2,580 units

Where it was sold

Why it was recalled

Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.

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 26, 2013 · Data as of Sep 19, 6:18 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.