The Recall Desk
ModerateFDA (Devices)·Z-1492-2017·Announced 2017-03-29

Philips CT Scanner Recall for Incorrect 4D CT Image Phase Annotations

Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.

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, but the source text explicitly states that no injuries or illnesses have been reported, and the hazard is a software annotation error rather than a direct physical injury risk.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 11 units of the Brilliance BigBore Oncology CT scanner (model 728243). The recall involves specific system serial numbers: 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, and 76025. These devices are distributed worldwide, including in the United States and various international markets.

The recall is due to a software issue affecting retrospective respiratory gated 4D CT scans performed with the Bellows pulmonary gating device. In these instances, the CT images may be reconstructed at a single phase, but the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).

Healthcare facilities using these specific serial numbers should contact Philips Medical Systems for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
Brilliance BigBore Oncology CT - 728243 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. These devices may include signal analysts and display equi
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
11

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 (11)

  • System Serial Number - 76002
  • 76008
  • 76010
  • 76011
  • 76016
  • 76020
  • 76021
  • 76022
  • 76023
  • 76024
  • 76025

Distribution

Distributed in 22 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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