http://badmedicaldevicesblog.com Just another WordPress weblog Tue, 09 Mar 2010 21:42:11 +0000 http://backend.userland.com/rss092 en Roex Inc. and the Federal Trade Commission have reached a settlement over claims the company made about its medical devices. Roex sold infrared saunas and dietary supplements through a radio infomercial, in print ads and on its Web site. The company and its two principles made false claims about the power ... http://badmedicaldevicesblog.com/2010/03/09/ftc-reaches-settlement-with-company-selling-infrared-saunas-as-therapy-for-terminal-disease/ Health officials are looking for ways to minimize risks from potentially dangerous malfunctions of insulin pumps used by tens of thousands of diabetics. Defective pumps can lead to high or low blood sugar if the machines fail to deliver the proper amount of insulin, which can be fatal. The FDA report did ... http://badmedicaldevicesblog.com/2010/03/04/fda-addresses-insulin-pump-problems/ Leading orthpaedic surgeons are expressing concern over metal-on-metal hip implants due to debris from the implanted device. In a New York Times report, surgeons at Rush University Medical Center in Chicago and the Mayo Clinic in Minnesota have expressed concern over the use of metal hip implant parts, used in about ... http://badmedicaldevicesblog.com/2010/03/04/metal-hip-devices-cause-problems-soon-after-surgery/ The Food and Drug Administration is classifying Baxter Healthcare Corp.'s latest recall as a Class I call-back, its most serious. According to a release from Baxter, the recall involves its HomeChoice and HomeChoice Pro peritoneal dialysis cyclers. Use of these medical devices could result in serious patient injuries or death. Should these ... http://badmedicaldevicesblog.com/2010/03/04/fda-issues-class-i-recall-on-dialysis-devices/ A Class 1 recall has been issued for Westwood, Massachusetts-based StatSpin Inc’s Express 4 Centrifuge by the FDA. FDA officials say the centrifuge can malfunction and send parts of the rotor and potentially contaminated blood flying out of the device. The rotor of the centrifuge can break and separate from the motor, ... http://badmedicaldevicesblog.com/2010/03/02/boston-scientific-charged-over-guidant-problems/ A Class 1 recall has been issued for Westwood, Massachusetts-based StatSpin Inc’s Express 4 Centrifuge by the FDA. FDA officials say the centrifuge can malfunction and send parts of the rotor and potentially contaminated blood flying out of the device. The rotor of the centrifuge can break and separate from the motor, ... http://badmedicaldevicesblog.com/2010/03/02/class-1-recall-issued-for-centrifuges/ The makers of most CT scanning devices will now use technology that alerts health care professionals to a potential radiatin overdose. We recently reported on the elevated radation levels reported among hundreds of patients at three Los Angeles-area hospitals in 2009. According to an AP report, the dosing checks on radiation amounts ... http://badmedicaldevicesblog.com/2010/03/02/group-says-makers-of-ct-scans-will-install-radiation-monitors/ LifeScan has issued a recall on some of its OneTouch SureStep diabetes test strips because they produce inaccurate results. In a statement from LifeScan Inc., eight lots of OneTouch SureStep Test Strips because they may provide falsely low glucose results when a level is actually higher than 400 mg/dL. The recall affects ... http://badmedicaldevicesblog.com/2010/03/01/lifescan-recalls-diabetes-test-strips-due-to-inaccurate-results/ The former head of the Food and Drug Administration branch that approved LASIK eye surgery in the 1990s says regulators underestimated the potential side effects. More than 700,000 LASIK eye surgeries are performed in the U.S. every year, and are designed to provide corrected, or near-perfect, vision to patients. Many people ... http://badmedicaldevicesblog.com/2010/02/26/former-fda-head-who-approved-lasik-surgery-now-has-second-thoughts/ The Food and Drug Administration is warning consumers to not use Ear Candles of any kind because they pose a risk of serious injury. Regulators say that even using Ear Candles according to manufacturer directions still holds the same risk. The FDA said it has no scientific evidence that Ear Candles ... http://badmedicaldevicesblog.com/2010/02/23/ear-candles-not-safe-fda-warns/