Philips Medical Systems (Cleveland) Inc: GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: -The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. -The detection, localization, and staging of tumors and diagnosing cancer patients. -Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Recall number

Z-0937-2012

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: -The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. -The detection, localization, and staging of tumors and diagnosing cancer patients. -Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Status

Terminated

Initiated

2011-10-24

Posted

2012-02-02

Terminated

2013-06-18

Reason

Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.

Root cause

Material/Component Contamination

Action

Philips Medical Systems (Cleveland) Inc communitcated the problem to the facilities via telephone. No customer letter was sent since the correction was already performed by the supplier.

Quantity

2

Distribution

Nationwide Distribution including Maryland and Colorado

Lot, serial or model codes

GEMINI TF 16 Serial Number 7224 & GEMINI TF 64 Serial Number 7217

510(k) numbers

["K052640"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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