Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Reported: December 23, 2015 Initiated: April 14, 2015 #Z-0408-2016
Product Description
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Reason for Recall
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 105
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips Healthcare Ingenuity CT Computed Tomography X-ray system. Recalled by Philips Electronics North America Corporation. Units affected: 105.
Why was this product recalled? ▼
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0408-2016.
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