The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Reported: October 8, 2014 Initiated: September 11, 2014 #Z-2711-2014
Product Description
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Reason for Recall
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 79
- Distribution
- Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 79.
Why was this product recalled? ▼
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 8, 2014. Severity: Moderate. Recall number: Z-2711-2014.
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