The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.

Jun 24, 2019 Diagnostic Equipment View Details →

BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spun Hematocrit.

Becton Dickinson & Company

Class I - Dangerous

The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.

Jun 3, 2019 Diagnostic Equipment View Details →

Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.

Canon Medical System, USA

Class I - Dangerous

software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed and there was no image available. It also showed the "OK" button to reacquire image data from the FPD, and the "Cancel" button to cancel the acquisition . When the user selects the "OK" button, the same message window appears. This prompted the user to repeat the same operation several times and finally select the "Cancel" button to quit the reacquistion mode.

Oct 16, 2018 Diagnostic Equipment Nationwide View Details →

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Helena Laboratories

Class I - Dangerous

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Aug 8, 2018 Diagnostic Equipment Nationwide View Details →

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Helena Laboratories

Class I - Dangerous

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Aug 8, 2018 Diagnostic Equipment Nationwide View Details →

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

Siemens Healthcare Diagnostics

Class I - Dangerous

A steady upward trend in blank (u) absorbance was observed

May 3, 2019 Diagnostic Equipment View Details →

Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM 230V 8170000027230 BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS 120V 8170000028120 BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

Medtronic Navigation, Inc.-Littleton

Class I - Dangerous

The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

May 1, 2019 Diagnostic Equipment Nationwide View Details →

ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.

ZOLL Medical

Class I - Dangerous

There is a potential for the device to fail to deliver energy to the patient.

Jun 12, 2019 Diagnostic Equipment Nationwide View Details →

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

Beckman Coulter

Class I - Dangerous

Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

Oct 18, 2018 Diagnostic Equipment Nationwide View Details →

VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Ortho-Clinical Diagnostics

Class I - Dangerous

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details →

Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

GE Healthcare

Class I - Dangerous

There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

May 16, 2019 Diagnostic Equipment Nationwide View Details →

VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Ortho-Clinical Diagnostics

Class I - Dangerous

Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Apr 8, 2019 Diagnostic Equipment Nationwide View Details →

Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Philips Medical Systems (Cleveland)

Class I - Dangerous

The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

Jun 3, 2019 Diagnostic Equipment Nationwide View Details →