Reported Aug 17, 2016 · Terminated

Brilliance iCT SP Model No. 728311; 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 SP Model No. 728311; To produce cross-sectional images of the body.
Lot codes and dates
  • Brilliance iCT SP Model No. 728311
  • S/N
    • 200107
    • 200003
    • 200011
    • 200009
    • 200017
    • 200074
    • 200022
    • 200013
    • 200027
    • 200049
    • 200032
    • 200030
    • 200043
    • 200040
    • 200038
    • 200047
    • 200051
    • 200044
    • 200063
    • 200061
    • 200068
    • 200067
    • 200089
    • 200088
    • 200092
    • 200093
    • 200101
    • 200097
    • 200100
    • 200105
    • 200109
    • 200121
    • 200204
    • 200111
    • 200117
    • 200127
    • 200131
    • 200200
    • 200205
    • 200138
    • 200202
    • 200201
    • 200203
    • 200209
    • 200210
    • 200206
    • 200208
    • 200207
    • 200211
    • 200019
    • 200015
    • 200029
    • 200024
    • 200023
    • 200025
    • 200026
    • 200041
    • 200086
    • 200102
    • 200213
Amount recalled
57 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 found in 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, 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.