Alerta De Seguridad para Navios flow cytometer

Safety alert

2013-01-22

2013-01-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130122.html

Medical device safety alert: beckman coulter navios flow cytometer the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning navios flow cytometer, manufactured by beckman coulter. the affected devices are a52101 navios 6 colours / 2 lasers; a52102 navios 8 colours / 2 lasers; and a52103 navios 10 colours / 3 lasers. the manufacturer has identified an internal wiring problem in certain navios reagent carts that may result in a severe shock hazard and instrument failure or shut down. during manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. normal vibration of the compressor frame could wear through the wiring’s shielding and insulation material and connect electrical current to the reagent cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard. no shocks to users or service personnel have been reported to date. the manufacturer advises users that if the compressor fails or the system shuts down unexpectedly, they should unplug from the laboratory power source and call beckman coulter customer service. the manufacturer will inspect affected devices and make corrections if an issue exists with the wiring within compressor module. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con224428 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 january 2013.