Recall – Tomagraphy system defect may result in image misdiagnosis

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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