Device Recall GC80 Digital Xray Imaging System 의 리콜

Recall

78679

Class 2

Z-0726-2018

2017-06-22

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160105

An image was obtained with over exposure during a thorax examination using the aec function.

On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.