Recalls and Safety Alerts:
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication
Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. FDA recommends that facilities using this device train staff and implement them as soon as possible...
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication
FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at a Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up...
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall
Some alarms on affected devices may fail to sound if therapy is interrupted...
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication (Updated)
Updated information for healthcare providers regarding duodenoscopes and reprocessing...
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall
Recall related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to FDA approval in 2012. Affected devices exhibit a higher susceptibility to electrostatic discharge than newer, commercial controllers...
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