Siemens Medical Solutions USA, Inc: Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative

Hazard

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

Details from the source

Reason for recall: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash. Distribution: US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA. Quantity: 2 systems Lot/code info: UDI-DI: N/A Serial Numbers: 18904 18906

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.