Current Newsletter: November 2016 (PDF - 524 KB)
Articles available within the current newsletter:
- In Brief - Recalls and Safety Alerts
- Medical Device Innovation Consortium (MDIC) Case for Quality Forum
- MedSun Survey Final Report - Mobile Medical Carts
- Highlighted Reports
- Links to FDA/CDRH Databases and Other Information Sources
Recalls and Safety Alerts:
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care ProvidersUpdate and additional information regarding the SynCardia temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System)...
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall HVAD pump recall due to a design problem with the driveline connector...
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall Recall due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient...
Radiation Therapy Devices by Multidata Systems International: Discontinue Use The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the U.S. for which FDA never received nor reviewed 510(k) premarket notifications...
Medtronic Neurovascular Products: Recall Recall due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices...
Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication FDA is updating its June 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of these devices...
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