Reported Sep 26, 2012 · Terminated

The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended…

Philips Medical Systems (Cleveland) Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Road · Cleveland, OH · 44143-2131

Is this the product you have?

  • The
  • Brilliance CT 16 System Product UsageThe Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles
Lot codes and dates
  • 96 of 96 codes

    • System Code #
    • 728246
    • Serial #
    • 6462
    • 6447
    • 6495
    • 6514
    • 6467
    • 6482
    • 6473
    • 6544
    • 6439
    • 6453
    • 6436
    • 6536
    • 6448
    • 6449
    • 6471
    • 6498
    • 6502
    • 6504
    • 6452
    • 6510
    • 6508
    • 6438
    • 6513
    • 6456
    • 6505
    • 6457
    • 6442
    • 6454
    • 6461
    • 6469
    • 6485
    • 6458
    • 6475
    • 6487
    • 6531
    • 6520
    • 6490
    • 6470
    • 6437
    • 6497
    • 6481
    • 6489
    • 6488
    • 6455
    • 6543
    • 6499
    • 6493
    • 6443
    • 6463
    • 6476
    • 6477
    • 6478
    • 6526
    • 6545
    • 6546
    • 6518
    • 6491
Amount recalled
93 units

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

Why it was recalled

Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Dec 24, 2013 · Data as of Sep 19, 6:13 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.