Medical

Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors

May 12, 2010 10:21 am | by FDA MedWatch | News | Comments

Reports of consumers ingesting the gel rather than using it topically, applied to the skin.

Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease

May 12, 2010 10:20 am | by FDA MedWatch | News | Comments

Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo.

Power Supplies Are Approved for BF-type Medical Apps

May 12, 2010 7:10 am | TDK-Lambda Americas, Inc. | Product Releases | Comments

TDK-Lambda’s NVM175 Series of medically approved AC-DC power supplies combine 4.5 kVAC reinforced input to output isolation with dual input fusing and an output-to-ground isolation of 1500 VAC. They meet UL/EN/IEC60601-1 and are suitable for

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

May 6, 2010 11:20 am | by FDA MedWatch | News | Comments

Flex tube may not fit securely within the endotracheal tube (ET) connector.

Retainer Clip for CompactFlash Provides Reliable Retention

May 5, 2010 7:26 am | 3M Electronics Solutions Division | Product Releases | Comments

A new device from the 3M Electronic Solutions Division provides reliable retention of CompactFlash Type I (CF I) and Type II (CF II) removable memory cards mated with 3M CF II card headers, helping to

6.5-inch Panel PC Operates In Extended Temperature Applications

May 5, 2010 7:07 am | Product Releases | Comments

WinSystems’ PPC3-G-6.5 is a 6.5-inch open frame, color flat panel PC based upon a PC-104-Plus single board computer (SBC) that operates from -20° to +70°C. The ready-to-mount flat panel display subsystem also includes a resistive touch screen integrated into a chassis approximately 2 inches thick. The open frame chassis (without a front bezel) permits

Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients

May 4, 2010 10:20 am | by FDA MedWatch | News | Comments

Patients to be informed of risk of severe injection site reactions.

Baxter Colleague Infusion Pumps: FDA Ordering Recall

May 4, 2010 6:20 am | by FDA MedWatch | News | Comments

Action based on failure to correct serious problems with infusion pumps.

GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer

May 3, 2010 10:20 am | by FDA MedWatch | News | Comments

Possible increased risk of diabetes and certain cardiovascular diseases.

Vita Breath Dietary Supplement

May 3, 2010 8:20 am | by FDA MedWatch | News | Comments

Consumers warned not to use product because it may contain hazardous levels of lead.

Panel PC Series for HMI Apps Includes 6.5- and 15-inch Touch Screens

May 3, 2010 7:35 am | Product Releases | Comments

VIA Technologies announced additions to its VIA VIPRO range of fanless touch screen panel PCs with the 6.5-inch VIA VIPRO VP7806 and 15-inch VIA VIPRO VP7815. Created using the flexible and modular Em-ITX form factor, these VIA VIPRO panel PCs are suitable for

McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall

April 30, 2010 8:20 pm | by FDA MedWatch | News | Comments

Certain over-the-counter Children’s and Infants’ liquid products may not meet required quality standards.

Wireless Sensor Platform for Hospitals Uses Virtualization Technology

April 28, 2010 8:34 am | News | Comments

LynuxWorks, Inc. has combined efforts with Portwell, Inc. to deliver a proof-of-concept (PoC) wireless sensor platform for hospitals based on Intel technology. When monitoring vital signs (such as EKG and blood oxygenation) during a

Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall

April 28, 2010 5:20 am | by FDA MedWatch | News | Comments

UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010

LCD Touts High Color Saturation, Fast Response Time

April 27, 2010 3:58 am | Product Releases | Comments

Lumex announced the launch of its InfoVue FSC (Field Sequential Color) family of color alphanumeric LCD displays for monochromatic devices looking to transition to color. These LCDs, compatible with standard LCD drivers, feature

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

April 24, 2010 6:20 am | by FDA MedWatch | News | Comments

Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

April 22, 2010 12:20 pm | by FDA MedWatch | News | Comments

Class I Recall issued because of the potential for the device to expectedly power off and/or power on.

Circular Connectors Enable Overmold Strain Relief Options

April 21, 2010 1:13 pm | Product Releases | Comments

Hirose Electric Co. has expanded its popular HR30 Circular Connector Series by developing an option that accepts a user-specified over-molded strain relief. The over-mold feature is ideal for demanding applications that require durability and environmental protection, in a cost effective package.

Propylthiouracil

April 21, 2010 11:20 am | by FDA MedWatch | News | Comments

[Updated 04/21/2010] FDA added a Boxed Warning to the label for propylthiouracil,to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients.

Data Acquisition and Display Station Is Optimized for Pharmaceutical Apps

April 15, 2010 6:43 am | Product Releases | Comments

Yokogawa’s DXAdvanced R4 has been added to the company’s DAQSTATION family data acquisition and display stations. Standard high capacity memory and a new option for stringent pharmaceutical applications are new features. The Advanced Security option delivers

Optocouplers Protect Patients, Operators Using Medical Equipment

April 15, 2010 6:13 am | Product Releases | Comments

Optocouplers are used in many industries to isolate an electrical signal between two elements of a circuit. There are many situations where signals and data need to be transferred from one system to another within a piece of electronic equipment without making a direct electrical connection.

Biocompatible Materials Drive the Success of Implantable Medical Devices

April 15, 2010 5:11 am | by Tom Kannally, Hypertronics Medical Industry Manager | Articles | Comments

The market for implantable medical devices is estimated at over $40 billion. The recent growth is spurred from significant contributions by the semiconductor industry where new chip technologies revolutionize health care treatments.

100 W to 150 W Power Supplies Are Medical andd ITE Safety Certified

April 14, 2010 6:57 am | TDK-Lambda Americas, Inc. | Product Releases | Comments

TDK-Lambda has unveiled its latest addition to its line of AC-DC medical and ITE (Information Technology Equipment) power supplies. The new single-output CSS150 100-W to150-W supplies accept a wide AC input range, have a low profile of 1.3” and a footprint of 3” x 5”, making them suitable for

Russia Performs Total Artificial Heart Implant

April 8, 2010 9:57 am | News | Comments

The Bakoulev Scientific Center for Cardiovascular Surgery (BSCCS) in Moscow performed Russia’s first implant of the SynCardia temporary CardioWest Total Artificial Heart. The patient, a 60-year-old female suffering from biventricular heart failure, is the world’s 850th recipient of the Total Artificial Heart.