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Recall Observatory FDA recall evidence

Device product

Philips Healthcare Ingenuity Core Computed Tomography X-ray system

Z-0406-2016

April 14, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 71926
Status
Terminated
Classification
Class II
Quantity
105
Official record key
device-enforcement:Z-0406-2016

Official wording

Reason: 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.

Code information: 728321

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.