The Recall Desk
HighFDA (Devices)·Z-2210-2013·Announced 2013-09-25

Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect

Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which corresponds to a High severity score under the rubric.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling specific models of Brilliance CT scanners, including the Brilliance CT 6, 16, 40, and 64. The recall involves 309 units distributed worldwide, including in the United States and numerous international locations.

The recall is due to a defect where the footswitch cover may impinge on the footswitch. This impingement can cause the patient support to move in an unintended manner. The affected units are identified by specific model and serial numbers listed in the official recall documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — CT Scanner
Hazard

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)

  • Model #
  • 728231
  • Serial #: 4021
  • 9535
  • 9544
  • 9587
  • 9627
  • 9701
  • 9707
  • 9713
  • 9759
  • 9875
  • 9887
  • 9917
  • 9925
  • 9931
  • 9980
  • 9996
  • 10009
  • 10011

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · unintended movement

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