FDAOctober 5, 2021device
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 recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Ongoing
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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