Reported Feb 14, 2018 · Terminated

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

    799 of 799 codes

    • 4001
    • 4016
    • 9056
    • 9067
    • 9071
    • 9074
    • 9099
    • 9112
    • 9134
    • 9194
    • 9213
    • 9235
    • 9251
    • 9263
    • 9268
    • 9269
    • 9272
    • 9280
    • 9367
    • 9515
    • 9515
    • 9521
    • 9529
    • 9538
    • 9541
    • 9548
    • 9549
    • 9554
    • 9559
    • 9561
    • 9573
    • 9574
    • 9579
    • 9584
    • 9600
    • 9607
    • 9614
    • 9618
    • 9625
    • 9631
    • 9633
    • 9638
    • 9640
    • 9646
    • 9649
    • 9653
    • 9656
    • 9659
    • 9667
    • 9670
    • 9678
    • 9686
    • 9688
    • 9689
    • 9703
    • 9707
    • 9711
    • 9720
    • 9738
    • 9740
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, 6:52 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.