The Recall Desk
HighFDA (Devices)·Z-0177-2016·Announced 2015-11-04

Philips Recalls Brilliance Big Bore CT Systems Due to X-ray Measurement Error

Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.

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 is classified as FDA Class II, and the hazard involves diagnostic imaging errors (artifacts) which pose a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 268 units of the Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. These devices are intended to produce cross-sectional images of the body. The recall covers Model No. 728243 and Model No. 728244, with specific serial numbers listed in the agency's structured data.

The firm discovered that the systems produce Ring/Dot artifacts due to X-ray measurement error. This defect affects the accuracy of the images generated by the equipment. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in most cases, cause temporary or medically reversible adverse health consequences.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and consumers with these specific models and serial numbers should contact Philips Medical Systems for further instructions on corrective actions.

The recalled product

Product
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
268

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. 728243
  • S/N: 7007
  • 7013
  • 7015
  • 7020
  • 7023
  • 7028
  • 7059
  • 7061
  • 7072
  • 7083
  • 7086
  • 7087
  • 7101
  • 7123
  • 7124
  • 7128
  • 7158
  • 7170
  • 7173

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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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