TY - JOUR
AB - Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE October 1, 2018 Volume 48 Do Health Care Professionals See FDA’s Number 17 IN THIS ISSUE Communications? Recalls & Field William A. Hyman, ScD Corrections—Class II Leica M320 Microscope We are familiar here with recalls, which typically involve direct Systems ...........................129 communications from manufacturers to customers and from the FDA and Olympus Uretero-reno other third-party communications. Direct communications from manufactures Endoscopes ....................130 have the challenge of reaching the right people, and those people recognizing Abbott CardioMEMS the recall for what it is and acting accordingly. Recognition is not always easy, Electronics Systems ........131 because recalls are often called something else by the manufacturer. Cardica C-Port xA Plus Anastomosis System .......131 But recalls are not the only communications that have safety implications, Reprocessed Harmonic and that users should be aware of. The FDA has multiple such Ace +7 Shears .................131 communications that are distributed to subscribers by e-mail and posted Proteus 235 Universal online. One is Safety Communication (SC) (https://www.fda.gov/ Nozzle ............................132 MedicalDevices/Safety/AlertsandNotices/ucm592582.htm). SCs may be about cobas m 511 Integrated specific devices, or a type of device. For example, there was an SC about 
TI - Abbott CardioMEMS Electronics Systems
JF - Biomedical Safety & Standards
DO - 10.1097/01.BMSAS.0000546284.12900.7e
DA - 2018-10-01
UR - https://www.deepdyve.com/lp/wolters-kluwer-health/abbott-cardiomems-electronics-systems-0tZOJz2fX6
SP - 131
EP - 131
VL - 48
IS - 17
DP - DeepDyve
ER -