The GC80 Digital X-ray Imaging System
FDA Recall Z-0726-2018 · Posted None
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Recalling FirmNeuroLogica Corporation
Recall StatusTerminated
Product CodeKPR
Date Initiated2017-06-22
Date Terminated2018-10-05
Product Quantity45 units
Reason for Recall
An image was obtained with over exposure during a Thorax examination using the AEC function.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide US
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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