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Philips North America, LLC recalls Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging
Recalled January 20, 2021 · FDA recall Z-0852-2021 · Philips North America
Hazard
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. · FDA Class II
Units
2714
Sold at
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.
Description
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Product
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.
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →