|
February 2017 MedSun Newsletter
Recalls and Safety Alerts:
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall
Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis…
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication – UPDATE
FDA is providing an important update to a 2016 Safety Communication to inform users about a design issue with this device that could increase the risk of patient infection…
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action
The company is contacting customers and advising them to immediately remove and reinstall the battery from their device(s)…
Duodenoscopes by Fujifilm Medical Systems: Safety Communication
Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use…
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication
The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment…
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication
The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient's physician, to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter…
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) |
 |
| 
