CLASS II Device recall · Reported 29 Aug 2012 · FDA Enforcement Report

Positron Emission Tomography (PET) recalled by Philips Medical Systems

Philips Medical Systems (Cleveland) is recalling Positron Emission Tomography (PET) and X-ray Computed Tomography, Gemini TF 16 PET/CT, distributed nationwide in the US. The recall was initiated on 8 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201

Quantity recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2239-2012
FDA event ID: 62892
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 8 Aug 2012
FDA classified: 22 Aug 2012
Reported: 29 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

8 Aug 2012	Recall initiated by company
22 Aug 2012	Classified by FDA	+14 days
29 Aug 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, 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, brain, 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. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.

Where it was distributed

Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.

Nationwide Colorado Florida Maryland Minnesota Nebraska Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

GEMINI TF 16 System serial numbers: 7194, 7186, 7235, 7233 GEMINI GXL 16 System serial number: 4201 GEMINI TF Big Bore System serial numbers: 9022, 9201

Where was it sold?

Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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