High FDA (Devices)·Z-0335-2014·Announced 2013-11-27

Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard

Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.

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 injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling nine units of the Brilliance iCT Computed Tomography X-Ray System. The recall involves Model #728306 with serial numbers 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024, and 100025.

The recall is due to a safety hazard where the footrest extension can contact the gantry cover or the user if the couch is positioned within the gantry bore and lowered. This risk is associated with the length of the accessory.

The affected units were distributed in the United States (DC, GA, IL, IN, NY, OH) and internationally in Germany, Israel, and the Netherlands. Users should contact the manufacturer for instructions on how to address this issue.

The recalled product

Product: Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System 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 — Imaging Equipment
Hazard: impact-injury
Affected units: 9

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 (9)

Model #728306
Serial #'s: 100016
100018
100019
100020
100021
100022
100023
100024 and 100025.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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