Recall Z-0852-2021 ยท LLZ System, Image Processing, Radiological
Philips North America, LLC
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.
| Date | Nov 19, 2020 |
| Status | Terminated |
| Reason | A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. |
| Root cause | 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 | 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, Isra |
| FDA record | Open on fda.gov |