Recall Z-2239-2012— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-08-08, terminated 2014-04-28. It names 3 FDA 510(k) clearances: K081135, K052640, K051170. Product: 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.. Reason: 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..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-08
- Terminated
- 2014-04-28
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
3 on FDA's recordK-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
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.