“Additionally, your firm has made 21 software upgrades since the release of the system, 17 of which were not evaluated for potential correction and removals. All of these software upgrades have been upgraded to all field systems. These software upgrades included fixes for identified hazards such as fluid deficit issues in software revisions G”, “L”, “N” and “S” all with an assigned severity level of “10”.
Your firm does not have evidence of review or acceptance of validated processes used by critical suppliers to manufacture components for your fluid management device.”
View the original warning letter.