Health Canada — Medical Devices · Canada · 2019-05-03 · Type III
As described by Health Canada — Medical Devices: Dimension Xpand System - Xpand Plus, Dimension EXL Analyzer with LM, Dimension EXL 200 Analyzer, Dimension Xpand System - Xpand Plus with HM Analyzer, Dimension RXL Max W/HM Analyzer (2019-04-07)
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Reported risk: Siemens Healthcare Diagnostics has identified the following three Dimension software version 10.3 behaviors inconsistent with expectations. Dimension software version 10.3 contains product improvements including enhanced security features as well as upgrade capabilities required for future software versions to be installed. All Dimension customers will receive software version 10.3. The unintended behaviors indicated in this letter do not impact the accuracy of patient results and will be corrected in the next version of dimension software currently being developed.
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