FDA 483 - Siemens Medical Solutions USA, Inc. - January 31, 2024

Siemens Medical Solutions USA, Inc. in Issaquah, WA, was inspected from January 23-31, 2024, and received a Form 483 for inadequate complaint handling procedures. The firm failed to properly escalate potential product issues related to its Class II ACUSON Diagnostic Imaging Systems to the Designated Complaint Unit, indicating a breakdown in their complaint management system.