A class I product recall has been issued by the FDA for the Puritan Bennett 840 Series Ventilator manufactured by Covidien. A software problem may cause the Ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.…
Some companies recently advertised the Nipple Aspirate Test as a method for breast cancer screening. The Nipple AspirateTest consists of using a breast pump to collect fluid from a woman’s nipple to screen for breast cancer. According the the FDA there is absolutely no clinical evidence to support these claims.…
Toy testing, toy recalls, toy related injuries and toy shopping will be the subject of the first Google+ Hangout hosted by the CSPC. John Massale, A CSPC engineer, will describe the toy testing process and spokeswoman Nikki Fleming will there to answer all your questions. You can post your questions…
Some defective Personal Emergency Reporting System (PERS) Transmitters are being recalled by Linear because the battery clips in the transmitters can corrode causing the transmitters to operate intermittently or not at all, without generating a warning. The recalled Linear PERS transmitters allow users to push a button on the transmitter…
22,483 potentially defective motorcycles are being recalled by Harley Davidson. These motorcycles may have a defective clutch system that may prevent the clutch from disengaging. Harley says if the clutch does not disengage, the rider may have difficulty slowing or stopping the motorcycle, increasing the risk of a motorcycle accident.…
A defective electrical component in Philips HeartStart defibrillators may fail to deliver a needed shock in case of emergency, warned the FDA yesterday. This safety alert by the FDA follows the recall by Philips of three models of its HeartStart devices in September 2012 due to an internal electrical malfunction.…
A defective air pressure switch in some Crown Home Heating Boilers can fail to shut down the burners allowing the boiler to emit excessive amounts of carbon monoxide, exposing consumers to CO poisoning hazard. Carbon monoxide poisoning is extremely dangerous because it is a deadly odorless gas. Carbon monoxide poisoning…
To prevent dangerous and defective products from reaching American consumers, the CPSC has been using a state-of-the-art risk assessment tool pilot called risk assessment methodology (RAM) for its port surveillance. As a result, the screenings led to the identification of about 680 shipments containing violative or defective products, totaling about…
All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 are being subjected to a FDA Class I recall because of a potential pressure sensor calibration drift. A calibration drift is a gradual degradation of the sensor…
Some potentially defective Anesthesia workstations and service kits manufactured by Spacelabs Helathcare are subject to a class I recall by the FDA. The recalled models are the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. These products are used in hospitals. They provide…