Philips North America, LLC Recall 86901
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.
Philips North America, LLC Recall 86901 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0852-2021 |
| Event ID | 86901 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 2714 |
| Recall Reason | A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient. |
| Device Classification | 20210120 |
| Device Code Info | Model# 882310,882311,882313 All Lots |
| Center Classification Date | 20210113 |
| Recall Initiation Date | 20201119 |
| Recalling Firm | Philips North America, LLC |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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