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Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. Class II

Reason: Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.

Cutera, Inc. 20131016 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Canada
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Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. Class II

Reason: A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

Synthes USA HQ, Inc. 20130930 Terminated
Distributed: Nationwide Distribution - only AZ .
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The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for primary diagnosis. The Centricity Enterprise Web is available as a supplemental sub-system to Centricity PACS or as a stand alone Web-based image and information distribution system. The Centricity Enterprise Web provides both the server software and a client application, which utilizes off the shelf browser technology. Centricity Enterprise Web supports several interface protocols which allows the system to be integrated with any image or information systems such as a hospital information system (HIS), radiology information system (RIS), or electronic medical record (EMR), which supports one of the supported integration protocols. Class II

Reason: GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an

Ge Healthcare It 20120419 Terminated
Distributed: US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.
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Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting. Class II

Reason: There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.

Sunrise Medical (US) LLC 20131111 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
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Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur. Class II

Reason: Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Synthes USA HQ, Inc. 20130730 Terminated
Distributed: Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
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Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures. Class II

Reason: Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

Abbott Point Of Care Inc. 20131028 Terminated
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,
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SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Class II

Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

CareFusion 303, Inc. 20131108 Terminated
Distributed: US Distribution in CA, WY, OH, UT, and MA.
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GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Class II

Reason: The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc 20130827 Terminated
Distributed: Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
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GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Class II

Reason: The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc 20130827 Terminated
Distributed: Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
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GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic Class II

Reason: The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Smith & Nephew Inc 20130827 Terminated
Distributed: Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
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