The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0594-2017·Announced 2016-11-23

Philips Brilliance CT System Recalled for Incorrect Label Rating

Philips is recalling three Brilliance ICT SP CT systems because the product labels do not include the correct current rating.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling three units of the Brilliance ICT SP Computed Tomography X-ray system, Model 728311. The recall is due to a labeling error where the product label does not include the correct current rating.

The affected units were distributed worldwide, including to specific facilities in the United States, Canada, and various international locations. The recall involves specific code numbers 200208, 200211, and 200213.

This is a Class III recall, indicating that the use of or exposure to the product is not likely to cause adverse health consequences. No specific instructions for consumers are provided in the source text, but the issue is limited to the accuracy of the label rating.

The recalled product

Product
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
3

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 (3)

  • 200208
  • 200211
  • 200213

Distribution

Distributed in 15 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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