California Dental Devicemaker Cited for Risk Assessment

The FDA dinged Chatsworth, California-based device manufacturer Patterson Dental Supply for failing to properly finish a risk assessment of its imaging software.

Agency inspections revealed that the firm didn’t perform a final risk assessment of its Dolphin Imaging software or identify and document additional potential risks.

Although multiple complaints over the past several years reported that the software generated identical ID numbers for patients, the company didn’t identify this as a risk. The issue could potentially lead to the wrong patients being treated, the agency said.