Medical
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
March 16, 2010 5:20 am | by FDA MedWatch | News | CommentsProduct sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
March 12, 2010 11:20 am | by FDA MedWatch | News | CommentsBoxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.
Counterfeit Polypropylene Surgical Mesh: Initial Communication
March 12, 2010 9:20 am | by FDA MedWatch | News | CommentsVarious sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
Baylis Medical Company Torflex Transseptal Guiding Sheath: Class I Recall
March 11, 2010 11:20 am | by FDA MedWatch | News | CommentsSheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
March 11, 2010 7:20 am | by FDA MedWatch | News | CommentsFDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
March 11, 2010 5:20 am | by FDA MedWatch | News | CommentsIncorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
DAC Helps Enable Clear Diagnostic Images
March 10, 2010 2:32 pm | Analog Devices, Inc. | Product Releases | CommentsAnalog Device’s AD5791 high-accuracy 20-bit digital-to-analog converter (DAC) is said to be the industry’s first to feature true 1-ppm (parts per million) resolution and accuracy, provides four times greater accuracy and four times more resolution than competing converters. The AD5791 features
Abiomed AB5000 Circulatory Support System: Class I Recall
March 10, 2010 12:20 pm | by FDA MedWatch | News | CommentsDevice computer may shut down without an alarm, which can lead to serious injuries or death.
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
March 10, 2010 8:20 am | by FDA MedWatch | News | CommentsCases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
March 8, 2010 10:20 am | by FDA MedWatch | News | CommentsUPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
March 5, 2010 8:21 am | by FDA MedWatch | News | CommentsSheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Compact Enclosures Suit a Wide Range of Applications
March 5, 2010 6:42 am | Product Releases | CommentsElma Electronic Inc. offers a family of modular enclosures in a compact size. The MiniBox 34 serves a wide range of applications including medical, communications, industrial, test and measurement, military/aerospace, and other markets. Its construction allows
Discrete Components Optimize Medical Equipment Performance and Reliability
March 4, 2010 10:16 am | by Steve Wade, VP of Sales and Marketing, TT electronics | Articles | CommentsMedical electronics applications require components that are smaller, more robust, and highly versatile, particularly as medical equipment becomes increasingly portable. Because medical systems often use discrete electronic components in their circuit designs, passive components are critical to optimizing performance and reliability.
Y-Flash to Improve Memory Size
March 4, 2010 5:35 am | Product Releases | CommentsTowerJazz announced its patented Y-Flash technology, not available from any other foundry in the industry, which is designed to give customers flexibility on memory size, allowing optimization of performance/cost for any given application.
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
March 3, 2010 7:20 am | by FDA MedWatch | News | CommentsReports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
Rochester Electronics reconstructs discontinued semiconductor devices
March 1, 2010 9:48 am | News | CommentsRochester Electronics, the world's largest authorized manufacturer of discontinued semiconductors, provides authorized reverse-engineering services to re-create, manufacture and distribute pin-for-pin replacement parts with matched cycle for cycle timing for aftermarket semiconductor devices. Through its unique Rochester Semiconductor Replication Process, customers can avoid system re-qualification steps as the Rochester-designed and manufactured parts deliver the same specifications and performance characteristics as the original products. Rochester engineers deconstruct and electrically analyze the critically needed semiconductor device, re-design the part using scope and scanning electron microscope (SEM) images, and re-engineer it onto a matched mature foundry process to replicate the original components.
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electroni...
February 27, 2010 8:20 am | by FDA (The Center for Devices and Radiological Health) | News | CommentsThe FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
OneTouch SureStep Test Strips (LifeScan): Recall
February 26, 2010 2:20 pm | by FDA MedWatch | News | CommentsTest strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
StatSpin Express 4 Centrifuges Model 510: Recall
February 26, 2010 9:20 am | by FDA MedWatch | News | CommentsRotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
Red LEDs Tout High Output
February 25, 2010 6:39 am | Product Releases | CommentsOpto Diode Corporation announced its OD-624L High Output Red LED. The LED has a dominant emission wavelength at 624 nm (typical) and features a narrow beam angle that is appropriate for fluorescence in medical, scientific testing instruments, and forensic applications. The lighting device delivers
Diode Laser Modules Deliver Digital Modulation at 200 MHz
February 25, 2010 6:35 am | Product Releases | CommentsVortran Laser Technology announced the Stradus family of laser diode modules that delivers digital modulation at 200 MHz. the product line is available in popular wavelengths used for biomedical, R&D and laboratory applications. Wavelengths include 660 nm at
Touchscreen Intelligent Displays Feature Pre-integrated Embedded Systems
February 24, 2010 12:09 pm | Product Releases | CommentsAnders Electronics announced the addition of a 5.7” VGA (640 x 480 pixel) resolution display to its UMR 5 Series of products. The new 5.7” VGA amorphous silicon-based TFT display with LED backlight is suitable for a variety of industrial and medical applications and offers
Compact 650W AC-DC Power Supply Suits Medical, Industrial Apps
February 24, 2010 11:46 am | Product Releases | CommentsXP Power introduced its SHP650 and MHP650 Series of single output high power density fan cooled AC/DC power supplies. The MHP650 range meets the IEC60601-1 safety specification for medical equipment, while the SHP650 range compiles with the
MIT commissions Peratech to develop next generation tactile robotic skin
February 23, 2010 11:27 am | News | CommentsPeratech Limited, the leader in new materials designed for touch technology solutions, has announced that they have been commissioned by the MIT Media Lab to develop a new type of electronic 'skin' that enables robotic devices to detect not only that they have been touched but also where and how hard the touch was.
Invirase (saquinavir): Ongoing safety review of clinical trial data
February 23, 2010 9:20 am | by FDA MedWatch | News | CommentsPossible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
