Reported Nov 4, 2015 · Terminated

Brilliance 64 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 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Lot codes and dates
  • Model No. 728231
  • S/N

    113 of 113 codes

    • 2
    • 9030
    • 9047
    • 9050
    • 9152
    • 9168
    • 9234
    • 9250
    • 9542
    • 9552
    • 9627
    • 9664
    • 9690
    • 9801
    • 9915
    • 9996
    • 9999
    • 10009
    • 10066
    • 10196
    • 10804
    • 10807
    • 29009
    • 29039
    • 29047
    • 29049
    • 29051
    • 29070
    • 29135
    • 29151
    • 90035
    • 90056
    • 90069
    • 90085
    • 90156
    • 90189
    • 90192
    • 95054
    • 95120
    • 95138
    • 95164
    • 95259
    • 95285
    • 95345
    • 95350
    • 95359
    • 95403
    • 95441
    • 95442
    • 95470
    • 95480
    • 95497
    • 95498
    • 95502
    • 95517
    • 95521
    • 95522
    • 95561
    • 95633
    • 95643
Amount recalled
108 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.

Free recall alerts

Get alerted about new Philips Medical Systems (Cleveland) Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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.