Cl II Philips GEMINI TF 16 slice PET/CT

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 7/29/2015
Class lI:

PRODUCT

GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Recall Number Z-2195-2015

REASON
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Cleveland, OH on 7/1/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.