PlainRecalls
FDA Devices Moderate Class II Terminated

Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body 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.

Reported: July 6, 2016 Initiated: April 1, 2016 #Z-2117-2016

Product Description

Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body 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.

Reason for Recall

Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

Details

Units Affected
18
Distribution
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled? ▼
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body 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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 18.
Why was this product recalled? ▼
Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2117-2016.

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