FDA 483 - Agiliti Health Inc. - August 27, 2019

Zetta Medical Technologies, LLC, a medical device manufacturer and CT assembler, was inspected by the FDA, revealing two significant observations. The firm's risk analysis was found to be inadequate, specifically regarding the definition of acceptable risk thresholds. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, lacking requirements for documenting unique device identifiers and evaluating medical device reporting.