Reported Aug 17, 2016 · Terminated

Brilliance iCT, Model No. 728306; 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 iCT, Model No. 728306; To produce cross-sectional images of the body.
Lot codes and dates
  • Brilliance iCT Model No. 728306
  • S/N

    358 of 358 codes

    • 85071
    • 85072
    • 100150
    • 100349
    • 100695
    • 100715
    • 100716
    • 100719
    • 100721
    • 100723
    • 100724
    • 100725
    • 100726
    • 100727
    • 100728
    • 100105
    • 100123
    • 100130
    • 100132
    • 100141
    • 100146
    • 100159
    • 100328
    • 100375
    • 100378
    • 100473
    • 100700
    • 100703
    • 100709
    • 100710
    • 100711
    • 100712
    • 100713
    • 100717
    • 100720
    • 100162
    • 85003
    • 85004
    • 85010
    • 85012
    • 85013
    • 85014
    • 85015
    • 85016
    • 85017
    • 85018
    • 85019
    • 85020
    • 85021
    • 85022
    • 85023
    • 85024
    • 85025
    • 85026
    • 85027
    • 85028
    • 85029
    • 85030
    • 85031
    • 85032
Amount recalled
335 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 issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP 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, 4:45 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.