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17 July 2017via FedExURGENT FIELD SAFETY NOTICE
MEDICAL DEVICE FIELD CORRECTION
Market/Data scope CS100i IntraAortic Balloon Pump (IAP)
Market/Data scope CS100 IntraAortic Balloon Pump (IAP)
Market/Data
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What is medical device field correction?
A field correction is action taken by a manufacturer at the distribution or user level to address a problem with a medical device that violates FDA regulations.
Who is required to file medical device field correction?
Manufacturers, importers, and distributors of medical devices are required to file a field correction with the FDA.
How to fill out medical device field correction?
Medical device field corrections can be filled out electronically using the FDA's electronic submission tools.
What is the purpose of medical device field correction?
The purpose of a medical device field correction is to address problems with a medical device that could pose a risk to patient safety.
What information must be reported on medical device field correction?
Information such as the reason for the field correction, affected product details, and action to be taken must be reported on a medical device field correction.
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