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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Model# 882310, 882311, 882313 All Lots
Products Sold
Model# 882310,882311,882313 All Lots
Philips North America, LLC is recalling Emission Computed Tomography System Image Process System - Product Usage: intended for general Nucle due to A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026