Reported Aug 17, 2016 · Terminated

Brilliance 64 CT Model 728231; 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 CT Model 728231; To produce cross-sectional images of the body.
Lot codes and dates
  • Model No. 728231
  • Brilliance 64 CT S/N

    150 of 150 codes

    • 9099
    • 9134
    • 9251
    • 9515
    • 9646
    • 9822
    • 9898
    • 9983
    • 10099
    • 10180
    • 10206
    • 10208
    • 91003
    • 95130
    • 95157
    • 95387
    • 95504
    • 4001
    • 9056
    • 9074
    • 9529 9538
    • 9549
    • 9554
    • 9573
    • 9574
    • 9618
    • 9625
    • 9638
    • 9653
    • 9656
    • 9659
    • 9667
    • 9670
    • 9686
    • 9689
    • 9703
    • 9738
    • 9740
    • 9755
    • 9782
    • 9811
    • 9833
    • 9837
    • 9838
    • 9859
    • 9862
    • 9901
    • 9909
    • 9910
    • 9917
    • 9920
    • 9923
    • 9927
    • 9930
    • 9933
    • 9989
    • 9993
    • 10021
    • 10024
    • 10042
Amount recalled
150

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 issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.

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, 6:01 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.