Recall Z-0852-2021— Philips North America, LLC

Name: FDA recall Z-0852-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-19

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-11-19, terminated 2023-04-19. It names 2 FDA 510(k) clearances: K061029, K042880. 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.. Reason: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Terminated: 2023-04-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K061029 — JETSTREAM WORKSPACEAdac Laboratories·cleared 2006-05-01
K042880 — JETSTREAM WORKSPACEAdac Laboratories·cleared 2004-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

Reason for recall

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Data sourced from openFDA. This site is unofficial and independent of the FDA.