Reported Aug 17, 2016 · Terminated

Brilliance 64 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 64 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
  • 319 of 319 codes

    • Model #: 728231
    • Serial #s: 9009
    • 9029
    • 9033
    • 9037
    • 9038
    • 9043
    • 9045
    • 9051
    • 9052
    • 9056
    • 9058
    • 9064
    • 9065
    • 9067
    • 9068
    • 9070
    • 9072
    • 9073
    • 9075
    • 9086
    • 9089
    • 9092
    • 9104
    • 9105
    • 9106
    • 9107
    • 9108
    • 9112
    • 9120
    • 9139
    • 9151
    • 9152
    • 9156
    • 9190
    • 9243
    • 9259
    • 9502
    • 9503
    • 9504
    • 9507
    • 9508
    • 9511
    • 9512
    • 9515
    • 9516
    • 9522
    • 9525
    • 9526
    • 9529
    • 9530
    • 9531
    • 9533
    • 9534
    • 9545
    • 9547
    • 9550
    • 9551
    • 9556
    • 9561
Amount recalled
318 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, 6:05 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.