The Recall Desk
ModerateFDA (Devices)·Z-1352-2016·Announced 2016-04-20

Philips Brilliance iCT CT Systems Recalled for Software Error

Philips Medical Systems is recalling 324 Brilliance iCT Computed Tomography systems due to a software error that may prevent automatic transmission of image data to remote devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a software error that may impede data transmission. No injuries, illnesses, or deaths are reported in the source text, and the risk is primarily functional rather than direct physical harm, fitting the criteria for a moderate severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 324 units of the Brilliance iCT Computed Tomography X-ray Systems. 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 notified of a software error. This error may cause the system to fail to automatically send all image and data series to remote devices. The affected units were distributed worldwide, including in the United States and numerous international countries.

Healthcare facilities and consumers should contact Philips Medical Systems for further instructions on how to address the software issue. The source text does not report any injuries or illnesses associated with this 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 (CT) Scanner
Hazard
Affected units
324

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 No. 728306
  • S/N: 85004
  • 85010
  • 85012
  • 85013
  • 85014
  • 85015
  • 85016
  • 85017
  • 85018
  • 85021
  • 85022
  • 85023
  • 85024
  • 85025
  • 85026
  • 85027
  • 85028
  • 85029
  • 85032

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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