The Recall Desk
LowFDA (Devices)·Z-2404-2012·Announced 2012-09-26

Philips Brilliance CT 16 System Recalled for Software Logout Failure

Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software defect requiring a manual restart, with no reported injuries or illnesses.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 93 units of the Brilliance CT 16 System. This is a whole-body computed tomography X-ray system intended to produce cross-sectional images of the body.

The recall was initiated because Philips was notified that the system logout function in software version 2.3.6 is longer than expected and may sometimes fail to log out. This failure may require a forced system restart or a hard shutdown using the power button.

The affected units were distributed worldwide, including in the United States and several international countries. No specific consumer action is detailed in the source text beyond the identification of the affected serial numbers.

The recalled product

Product
The Brilliance CT 16 System Product Usage: The 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.
Affected units
93

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • System Code #
  • 728246
  • Serial #
  • 6462
  • 6447
  • 6495
  • 6514
  • 6467
  • 6482
  • 6473
  • 6544
  • 6439
  • 6453
  • 6436
  • 6536
  • 6448
  • 6449
  • 6471
  • 6498
  • 6502

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically: