Reported Nov 4, 2015 · Terminated

Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional…

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?

  • Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Lot codes and dates
  • Model No. 728243
  • S/N

    235 of 235 codes

    • 7007
    • 7013
    • 7015
    • 7020
    • 7023
    • 7028
    • 7059
    • 7061
    • 7072
    • 7083
    • 7086
    • 7087
    • 7101
    • 7123
    • 7124
    • 7128
    • 7158
    • 7170
    • 7173
    • 7178
    • 7193
    • 7204
    • 7214
    • 7221
    • 7228
    • 7231
    • 7235
    • 7246
    • 7262
    • 7265
    • 7273
    • 7284
    • 7328
    • 7347
    • 7353
    • 7364
    • 7365
    • 7370
    • 7395
    • 7400
    • 7403
    • 7434
    • 7435
    • 7462
    • 7467
    • 7481
    • 7484
    • 7596
    • 7612
    • 7775
    • 7794
    • 7795
    • 7803
    • 7840
    • 7841
    • 7842
    • 7843
    • 7846
    • 7847
    • 7848
  • S/N
    • 7121
    • 7176
    • 7271
    • 7595
    • 7764
    • 7844
    • 7845
    • 7862
    • 7870
    • 7871
    • 7874
    • 7878
    • 7879
    • 7880
    • 7882
    • 7887
    • 7894
    • 7897
    • 7899
    • 7903
    • 7906
    • 7912
    • 7913
    • 7915
    • 7917
    • 7919
    • 7922
    • 7926
    • 7930
    • 7934
    • 7952
    • 7957
    • 7958
    • 7959
    • 7964
    • 7965
    • 7967
    • 7979
    • 7981
    • 7986
    • 7988
    • 75106 & 75110
Amount recalled
268 units total

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

The firm discovered Ring/Dot artifact due to X-ray measurement error.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 26, 2018 · Data as of Sep 19, 6:00 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.