Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit 의 리콜

Recall

RC-2017-RN-00213-1

Class I

2017-02-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00213-1

The prager shell is supplied as an accessory with the ellex ‘eyecubed v4' and ‘eyeone’ ophthalmic ultrasound diagnostic device. prager shells are reusable semi critical devices requiring high level disinfection. they are required to be cleaned and disinfected before the first use and between patient uses.An issue has been identified with the manufacturer's instructions for use (ifu) for the prager shell. this ifu does not provide adequate details on the cleaning and disinfection procedures. validated cleaning and disinfection procedures, which will provide the required level of cleaning and disinfection, have been included in a revised version of the ellex prager shell care instructions. to date, there have been no adverse events reported to ellex for the prager shells.

Ellex is advising customers with affected stock to ensure that cleaning and disinfection procedures of the Prager shell are performed in accordance with the “Ellex Prager Shell Care Instructions” supplied.