The Recall Desk
HighFDA (Devices)·Z-1656-2015·Announced 2015-06-03

Philips Brilliance iCT CT Systems Recalled for Unexpected Couch Descent

Philips Medical Systems is recalling 153 Brilliance iCT computed tomography systems because the patient couch may unexpectedly descend during an exam.

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 where the patient couch may unexpectedly descend, posing a potential injury risk, but the source text does not report any actual injuries or illnesses.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance iCT computed tomography (CT) system. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

The recall was initiated after the firm was informed that while raising the patient couch to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. This unexpected movement poses a risk of injury to patients or operators.

The affected units were distributed in China. The specific system code is 728306, and the affected serial numbers are 100067, 100137, 100179, 100226, 100233, 100293, 100294, and 100342. Users of these systems should contact Philips Medical Systems for further instructions on how to address the defect.

The recalled product

Product
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
153

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 (10)

  • System Code #
  • 728306
  • Serial #
  • 100067
  • 100137
  • 100179
  • 100226
  • 100233
  • 100293
  • 100294 & 100342.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 11 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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