Reported Jan 31, 2018 · Terminated

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

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?

  • Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Lot codes and dates
  • Brilliance iCT 4.1.6 version
  • Brilliance iCT - Model 728306 Codes

    495 of 495 codes

    • 100688
    • 85025
    • 100790
    • 100490
    • 100667
    • 85054
    • 100408
    • 100604
    • 85031
    • 100703
    • 100411
    • 100114
    • 100314
    • 100278
    • 100349
    • 100654
    • 100406
    • 100452
    • 100453
    • 100404
    • 100242
    • 100115
    • 100383
    • 100189
    • 100347
    • 100348
    • 100450
    • 100748
    • 100507
    • 100181
    • 100469
    • 200005
    • 100638
    • 100195
    • 100101
    • 100440
    • 100223
    • 100616
    • 100619
    • 100134
    • 100304
    • 100656
    • 100436
    • 100773
    • 100130
    • 100621
    • 100113
    • 85055
    • 100600
    • 100180
    • 85060
    • 100704
    • 100750
    • 85041
    • 100737
    • 100231
    • 100615
    • 100612
    • 100393
    • 100643
Amount recalled
559 total

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

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, 2019 · Data as of Sep 19, 4:44 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.