Reported Nov 4, 2015 · Terminated

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

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 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Lot codes and dates
  • Model No. 728246
  • S/N

    331 of 331 codes

    • 3007
    • 3016
    • 3047
    • 3095
    • 3127
    • 3331
    • 3359
    • 3410
    • 3478
    • 3482
    • 3500
    • 3679
    • 3702
    • 4042
    • 5049
    • 5067
    • 5068
    • 5072
    • 5073
    • 5094
    • 5097
    • 5143
    • 5169
    • 5174
    • 5223
    • 5249
    • 5297
    • 5317
    • 5368
    • 5439
    • 5546
    • 5638
    • 5663
    • 5703
    • 5728
    • 5740
    • 5741
    • 5916
    • 5928
    • 5971
    • 6028
    • 6030
    • 6052
    • 6061
    • 6067
    • 6070
    • 6085
    • 6090
    • 6107
    • 6111
    • 6117
    • 6133
    • 6147
    • 6153
    • 6156
    • 6161
    • 6162
    • 6231
    • 6255
    • 6491
Amount recalled
323 units

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, 5:37 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.