Emission Computed Tomography System Image Process recall: Software Issue
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of…
Why was Emission Computed Tomography System Image Process recalled?
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model# 882310,882311,882313 All Lots
- Product
- Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of…
- Recalling firm
- Philips North America, LLC
- Quantity
- 2714
- Distribution
- 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.
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)