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Other Medical Devices

Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.

Boston Scientific

Class I - Dangerous

There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.

Jan 12, 2017 Other Medical Devices Nationwide View Details →

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

Immuno-Mycologics

Class I - Dangerous

The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.

Dec 27, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

Flower Orthopedics

Class I - Dangerous

The product is being recalled due to incidence and reports of the product breaking during surgery.

Dec 22, 2016 Other Medical Devices View Details →

Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

Olympus Scientific Solutions Americas

Class I - Dangerous

It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

Jan 7, 2017 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143

Organ Recovery Systems

Class I - Dangerous

Organ preservation fluid recalled due to potential for bacterial contamination.

Dec 14, 2016 Other Medical Devices Nationwide View Details →

Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

Siemens Medical Solutions USA

Class I - Dangerous

Software error

Jan 11, 2017 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787 27788 27789 27794 27812 27814 27815 27816 27817 27818 27820 27821 27822 27823 27824 27825 27827 27828 27830 27831 27832 27848 27864 27867 27868 27888 27903 27922 27823 27924 23042 27925 27926 27927 27932 27933 42335 42355 42365 42836 42856 42866 44420 44421 44430 44465 46070 46075 46080 46085 46635 46655 46665 46836 46856 46866 46871 46876 46881 46886 92355 92365 92856 92866 96655 96665

Medtronic Neurosurgery

Class I - Dangerous

Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

Mevion Medical Systems

Class I - Dangerous

An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

Dec 16, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Medtronic Advanced Energy

Class I - Dangerous

Product sterility compromised due to breach of sterile barrier

Dec 28, 2016 Other Medical Devices Nationwide View Details →

OEC 9900 Elite. MDL Numbers: D148942, D155043

GE OEC Medical Systems

Class I - Dangerous

GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

Dec 27, 2016 Other Medical Devices View Details →

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