A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
Reason for recall: A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI). Distribution: Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE. Quantity: 11 units Lot/code info: GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
00198953056752
Official record: FDA (Device enforcement) ↗
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