Reported Aug 17, 2016 · Terminated

Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer…

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 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 #: 728321
    • Serial #s: 310004
    • 310005
    • 310012
    • 310016
    • 310020
    • 310021
    • 310027
    • 310028
    • 310033
    • 310034
    • 310041
    • 310044
    • 310045
    • 310057
    • 310061
    • 310065
    • 310072
    • 310074
    • 310076
    • 310077
    • 310078
    • 310094
    • 310099
    • 310100
    • 310103
    • 310105
    • 310117
    • 310120
    • 310135
Amount recalled
29 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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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, 5:20 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.