Reported Aug 17, 2016 · Terminated

Ingenuity Core 128 Computed Tomography X-ray systems is 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 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Lot codes and dates
    • Model #: 728323
    • Serial #s: 310067
    • 320002
    • 320004
    • 320053
    • 320056
Amount recalled
5 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 defect causing intermittently slow response of Host.

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

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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, 2018 · Data as of Sep 19, 6:00 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.