FDA-Device2022-06-15Class II
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Siemens Medical Solutions USA, Inc
Hazard
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Sold states
Domestic distribution nationwide.
Affected count
443
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2022Don't want to check this manually?
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