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.
Recall
- Recall Number
- Z-0852-2021
- Event Number
- 86901
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 19, 2020
- Terminated
- April 19, 2023
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
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.
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
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.
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.
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