Company: Philips North America, LLC
Date of Enforcement Report: 1/20/2021
Class II
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.
Recall Number: Z-0852-2021
REASON
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
RECALLING FIRM/MANUFACTURER
Philips North America, LLC on 11/23/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2714
DISTRIBUTION
U.S. Nationwide and International