If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
Reason for recall: If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm. Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ, NM, NY, OH, VA, WA and the countries of Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, United Kingdom. Quantity: 555 units Lot/code info: GTIN: N/A Serial Numbers: D0122190G0002 D0122190G0004 D0122190G0005 D0122190G0006 D0122190G0008 D0122190G0009 D0122190G0010 D0122190G0011 D0122190G0012 D0122190G0013 D0122190G0016 D0122190G0017 D0122190G0018 D0122190G0019 D0122190G0020 D0122190G0021 D0122190G0022 D0122190G0023 D0122190G0024 D0122190G0025 D0122190G0026 D0122190G0027 D0122190G0028 D0122190G0029 D0122190G0032 D0122190G0034 D0122190G0035 D0122190G0036 D0122190G0037 D0122190G0041 D0122190G0042 D0122190G0043 D0122190G0047 D0122190G0049 D0122190G0050 D0122190G0051 D0122190G0052 D0122190G0055 D0122190G0056 D0122190G0058 D0122190G0060 D0122190G0061 D0122190G0063 D0122190G0064 D0122190G0065 D0122190G0066 D0122190G0067 D0122190G0068 D0122190G0069 D0122190G0070 D0122190G0072 D0122190G0073 D0122190G0074 D0122190G0076 D0122190G0077 D0122190G0078 D0122190G0079 D0122190G0080 D0122190G0081 D0122190G0082 D0122190G0083 D0122190G0084 D0122190G0085 D0122190G0086 D0122190G0087 D0122190G0088 D0122190G0089 D0122190G0090 D0122190G0091 D0122190G0094 D0122190G0096 D0122190G0097 D0122190G0099 D0122190G0100 D0122190G0101 D0122190G0103 D0122190G0105 D0122190G0106 D0122190G0107 D0122190G0108 D0122190G0109 D0122190G0110 D0122190G0112 D0122190G0113 D0122190G0114 D0122190G0115 D0122190G0116 D0122190G0117 D0122190G0118 D0122190G0119 D0122190G0120 D0122190G0121 D0122190G0123 D0122190G0124 D0122190G0125 D0122190G0126 D0122190G0129 D0122190G0131 D0122190G0132 D0122190G0133 D0122190G0134 D0122190G0135 D0122190G0136 D0122190G0137 D0122190G0138 D012
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.