Reported Feb 14, 2018 · Terminated

Philips Ingenuity Core 128 computed tomography x-ray system

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?

  • Philips Ingenuity Core 128 computed tomography x-ray system
Lot codes and dates
  • Ingenuity Core 128 - 728323 SN# -

    630 of 630 codes

    • 320002
    • 320001
    • 320006
    • 320003
    • 320005
    • 320010
    • 320008
    • 320030
    • 320037
    • 320019
    • 320033
    • 320018
    • 320024
    • 320029
    • 320026
    • 320031
    • 320059
    • 320054
    • 320058
    • 320074
    • 320081
    • 336207
    • 320079
    • 320078
    • 320069
    • 320080
    • 320073
    • 320115
    • 320092
    • 320090
    • 320083
    • 320084
    • 320082
    • 320096
    • 320133
    • 320103
    • 320100
    • 320101
    • 336015
    • 320138
    • 32021
    • 320107
    • 320111
    • 320132
    • 320126
    • 320114
    • 336016
    • 320248
    • 320123
    • 336011
    • 320099
    • 320122
    • 336018
    • 320134
    • 320215
    • 320146
    • 320119
    • 336013
    • 320125
    • 320131
Amount recalled
N/A

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Why it was recalled

Numerous issues related to software Brilliance iCT 4.1.6 software version.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 2019 · Data as of Sep 19, 5:29 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.