Reported Apr 23, 2014 · Terminated

Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.

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?

  • Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Lot codes and dates
  • System code

    107 of 107 codes

    • 728323
    • Serial #: 320002
    • 320003
    • 320004
    • 320005
    • 320006
    • 320007
    • 320008
    • 320009
    • 320010
    • 320011
    • 320013
    • 320014
    • 320015
    • 320017
    • 320018
    • 320019
    • 320020
    • 320022
    • 320023
    • 320024
    • 320025
    • 320026
    • 320027
    • 320028
    • 320029
    • 320031
    • 320032
    • 320034
    • 320035
    • 320036
    • 320037
    • 320038
    • 320039
    • 320040
    • 320041
    • 320043
    • 320044
    • 320045
    • 320046
    • 320047
    • 320048
    • 320049
    • 320050
    • 320051
    • 320052
    • 320053
    • 320054
    • 320055
    • 320056
    • 320057
    • 320059
    • 320060
    • 320062
    • 320063
    • 320064
    • 320065
    • 320066
    • 320067
    • 320068
Amount recalled
116 units

This recall covers 2 products

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

Where it was sold

Why it was recalled

A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.

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 Nov 5, 2014 · Data as of Sep 19, 6:07 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.