Siemens Medical Solutions USA, Inc: Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electroph

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: 12 units Lot/code info: UDI-DI: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 102183

UPC codes

4056869010199

Source

Official record: FDA (Device enforcement) ↗

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