FDA-Device2021-01-20Class II
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Philips North America, LLC
Hazard
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Latvia, Libya, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Kingdom, Venezuela.
Affected count
2714
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2021Don't want to check this manually?
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