Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01098-1

Class II

2017-08-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01098-1

There is the potential for a short circuit between the pcb (printed circuit board) and heater transistor or a malfunction of the transistor with the sysmex cs-5100. this may lead to smoke from the instrument, and in a worst case scenario, the overcurrent damaging the pcb, which may lead to a melting of the transistors until the instrument is powered off. this failure mode will occur if all of the conditions below are met:- pcb protection component blocks overcurrent by the short circuit- pcb protection component has a breakdown after a certain period with the instrument turned on- the overcurrent is throughout the pcb, which may lead to burn out unless the instrument is powered off.

Follow the instructions provided by Sysmex and confirm receipt of the information issued in August 2017. Complete and return the Response Form attached to the customer letter by Friday 22nd of September 2017. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files and forward this information to all parties that may use a Sysmex CS-5100 system. A Siemens field service representative will visit and disconnect the connector on the PCB.