Reported Dec 14, 2016 · Terminated

Ingenuity Core 728321 Computed Tomography X-ray systems 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?

  • Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Lot codes and dates
  • 328 of 328 codes

    • 30041
    • 31001
    • 33084
    • 52000
    • 52004
    • 52007
    • 52008
    • 52010
    • 52012
    • 52013
    • 52014
    • 52015
    • 52018
    • 52019
    • 52020
    • 52021
    • 52022
    • 52024
    • 52025
    • 52026
    • 52027
    • 52029
    • 52030
    • 52031
    • 52032
    • 52033
    • 52034
    • 52035
    • 52036
    • 52037
    • 52038
    • 52039
    • 52040
    • 52041
    • 52042
    • 52043
    • 52044
    • 52045
    • 52046
    • 52047
    • 52048
    • 52050
    • 52052
    • 52053
    • 52054
    • 52055
    • 52056
    • 52057
    • 52058
    • 52059
    • 52061
    • 52063
    • 52064
    • 52065
    • 52067
    • 52068
    • 52069
    • 52070
    • 52071
    • 52072
Amount recalled
337

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

Why it was recalled

Software error due to the filament on timer

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 Jun 18, 2019 · Data as of Sep 19, 5:21 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.