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.
- Company
- Philips North America, Llc
- Recall Initiated
- November 19, 2020
- Terminated
- April 19, 2023
- Recall Number
- Z-0852-2021
- Quantity
- 2714
- Firm Location
- Andover, MA
Reason for Recall
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
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.
Lot / Code Info
Model# 882310,882311,882313 All Lots
Root Cause
Device Design
Action Taken
On 11/23/2020, Philips issued Urgent Device Correction notices to customers via press release, letter, telefax, telephone, e-mail, visit, etc. Due to a software defect Philips is notifying all affected users of the JETStream Workspace Thyroid Analysis application recommending that customers calculate thyroid uptake utilizing the method provided in the notices and not using the Transfer Coefficient parameter.