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Class 2 Device Recall JETStream Workspace |
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Date Initiated by Firm |
November 19, 2020 |
Create Date |
January 13, 2021 |
Recall Status1 |
Terminated 3 on April 19, 2023 |
Recall Number |
Z-0852-2021 |
Recall Event ID |
86901 |
510(K)Number |
K042880 K061029
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Product Classification |
System, image processing, radiological - Product Code LLZ
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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
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For Additional Information Contact |
Holly Wright Lee 440-483-2015
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Manufacturer Reason for Recall |
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
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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
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = ADAC LABORATORIES
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