Reported Aug 17, 2016 · Terminated

Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer…

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 Computed Tomography X-ray systems 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
  • 204 of 204 codes

    • Model #: 728246
    • Serial #s: 3010
    • 3017
    • 3031
    • 3040
    • 3043
    • 3070
    • 3072
    • 3085
    • 3090
    • 3117
    • 3123
    • 3149
    • 3179
    • 3216
    • 3247
    • 3293
    • 3314
    • 3324
    • 3411
    • 3465
    • 3490
    • 5006
    • 5009
    • 5012
    • 5018
    • 5020
    • 5024
    • 5026
    • 5028
    • 5030
    • 5031
    • 5035
    • 5044
    • 5045
    • 5048
    • 5052
    • 5053
    • 5054
    • 5055
    • 5058
    • 5059
    • 5060
    • 5064
    • 5069
    • 5070
    • 5075
    • 5077
    • 5081
    • 5086
    • 5088
    • 5091
    • 5093
    • 5097
    • 5099
    • 5101
    • 5103
    • 5107
    • 5108
    • 5110
Amount recalled
203 units

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Where it was sold

Why it was recalled

Software defect causing intermittently slow response of Host.

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 Jul 2, 2018 · Data as of Sep 19, 6:46 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.