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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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....Read More