Reported Feb 5, 2014 · Terminated

Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by…

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 and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
Lot codes and dates
  • 503 of 503 codes

    • Model # 728306 100016
    • 100018
    • 100019
    • 100020
    • 100021
    • 100022
    • 100023
    • 100024
    • 100025
    • 100028
    • 100031
    • 100032
    • 100037
    • 100038
    • 100039
    • 100040
    • 100042
    • 100043
    • 100044
    • 100045
    • 100046
    • 100047
    • 100048
    • 100049
    • 100050
    • 100051
    • 100052
    • 100053
    • 100054
    • 100055
    • 100056
    • 100057
    • 100058
    • 100059
    • 100060
    • 100061
    • 100062
    • 100063
    • 100064
    • 100065
    • 100066
    • 100067
    • 100068
    • 100069
    • 100070
    • 100071
    • 100072
    • 100073
    • 100074
    • 100077
    • 100078
    • 100079
    • 100081
    • 100082
    • 100083
    • 100084
    • 100085
    • 100086
    • 100087
    • 100088
Amount recalled
506

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

An artifact that resembles thrombus may appear on the image.

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 Sep 19, 2014 · Data as of Sep 19, 6:12 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.