Day

July 29, 2015
Company:Volcano Corporation Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT 1) Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. Recall Number Z-2200-2015 REASON Philips, Pinnacle Radiation Treatment Planning System version 9 0, 9 2 9 4, 9 6 is being recalled because the dose may...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI GXL 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-2193-2015 REASON Philips has...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Ready 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-2197-2015 REASON Philips has identified...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Big Bore 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-2199-2015 REASON Philips has...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Base 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-2198-2015 REASON Philips has identified...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 64 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-2196-2015 REASON Philips has...
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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...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI LXL 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-2194-2015 REASON Philips has identified four...
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Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation....
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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
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