Reported Aug 17, 2016 · Terminated

Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.

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 CT Model No. 728326; To produce cross-sectional images of the body.
Lot codes and dates
  • Ingenuity CT Model No. 728326
  • S/N

    211 of 211 codes

    • 300004
    • 30003
    • 30005
    • 30006
    • 30007
    • 30008
    • 30009
    • 30010
    • 30011
    • 30012
    • 30013
    • 30014
    • 30015
    • 30017
    • 30018
    • 30019
    • 30020
    • 30021
    • 30022
    • 30025
    • 30026
    • 30027
    • 30028
    • 30029
    • 30030
    • 30031
    • 30032
    • 30033
    • 30034
    • 30036
    • 30037
    • 30038
    • 30039
    • 30040
    • 30041
    • 30042
    • 30043
    • 30044
    • 30045
    • 30046
    • 32083
    • 300015
    • 300033
    • 300037
    • 300038
    • 300045
    • 300054
    • 300057
    • 300066
    • 300068
    • 300072
    • 300081
    • 300082
    • 300084
    • 300089
    • 300091
    • 300107
    • 300109
    • 300120
    • 300122
Amount recalled
205 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 issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.

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, 2018 · Data as of Sep 19, 5:59 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.