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Siemens Medical Solutions USA, Inc recalls Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658
Recalled June 15, 2022 · FDA recall Z-1243-2022 · Siemens Medical Solutions USA
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. · FDA Class II
Units
443
Sold at
Domestic distribution nationwide.
Description
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.
Product
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →