FDA-Device2021-11-24Class II
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Siemens Medical Solutions USA, Inc
Hazard
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
Sold states
Nationwide
Affected count
403 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2022Don't want to check this manually?
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