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