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Diagnostic Equipment

🏥 Medical Devices • 6,627 recalls

Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Ethicon Endo-Surgery

Class I - Dangerous

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Apr 11, 2019 Diagnostic Equipment Nationwide View Details →

Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

Siemens Medical Solutions USA

Class I - Dangerous

Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists

Mar 22, 2019 Diagnostic Equipment Nationwide View Details →

Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.

Medica

Class I - Dangerous

Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.

Feb 6, 2019 Diagnostic Equipment Nationwide View Details →

Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

Siemens Medical Solutions USA

Class I - Dangerous

Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.

Mar 18, 2019 Diagnostic Equipment Nationwide View Details →

Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

Elekta Limited

Class I - Dangerous

There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

Apr 3, 2019 Diagnostic Equipment Nationwide View Details →

NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT 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 system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.

GE Healthcare

Class I - Dangerous

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

Mar 20, 2019 Diagnostic Equipment View Details →

NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health 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

GE Healthcare

Class I - Dangerous

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

Mar 20, 2019 Diagnostic Equipment View Details →
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