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U.S. Department of Health and Human Services

Class 2 Device Recall JETStream Workspace

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  Class 2 Device Recall JETStream Workspace see related information
Date Initiated by Firm November 19, 2020
Create Date January 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-0852-2021
Recall Event ID 86901
510(K)Number K042880  K061029  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Model# 882310,882311,882313 All Lots
Recalling Firm/
Manufacturer
Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = ADAC LABORATORIES
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