In the context of FDA device recalls, what does 'Correction' mean?

• A. Removal of the product from the market
• B. Repair, modification, adjustment, relabeling, destruction, or inspection without removal to another location
• C. Relocation of the product to a different facility
• D. A simple patient notification

Answer: (B)

Correction means actions taken to fix a problem in devices already in use, without removing them from use or moving them to another location. It covers repairing, modifying, or adjusting the device; relabeling or updating instructions for use; destruction of nonconforming units; or inspecting devices at the site where they are being used. This is different from removal, which involves taking the device out of the market or away from users. A patient notification alone isn’t the corrective action unless it accompanies a field remediation, such as an on-site software update or calibration. For example, performing a software update or a field calibration at the hospital, or relabeling the device to reflect new instructions, would be considered a correction.