🍔 Food 💊 Drugs 🏥 Medical Devices
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system Class II

Reason: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

Siemens Medical Solutions USA, Inc 20130903 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
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ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations Class II

Reason: Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

Ivoclar Vivadent, Inc. 20130923 Terminated
Distributed: US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
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Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. Class II

Reason: Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.

Stryker Spine 20130924 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
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GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. Class II

Reason: GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.

GE Healthcare, LLC 20131011 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
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*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration. Class II

Reason: Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.

Hospira Inc. 20130828 Terminated
Distributed: US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
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Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. Class II

Reason: The lift might fail with the labeled 500-lb. load rating.

Ergosafe Products LLC DBA Prism Medical Services USA 20131030 Terminated
Distributed: Nationwide distribution.
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Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. Class II

Reason: The lift might fail with the labeled 500-lb. load rating.

Ergosafe Products LLC DBA Prism Medical Services USA 20131030 Terminated
Distributed: Nationwide distribution.
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Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. Class II

Reason: A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

Synthes USA HQ, Inc. 20131003 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
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EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. Class II

Reason: A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

Philips Medical Systems North America Inc. 20131017 Terminated
Distributed: Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.
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GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. - The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann Class II

Reason: GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a

GE Healthcare, LLC 20131025 Terminated
Distributed: Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and UNITED KINGDOM.
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