Siemens Medical Solutions USA, Inc Recall 87515
Description: Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology
Siemens Medical Solutions USA, Inc Recall 87515 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1434-2021 |
| Event ID | 87515 |
| Event Description | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 88 units |
| Recall Reason | Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions |
| Device Classification | 20210428 |
| Device Code Info | Serial Numbers: 15915 15916 103137 103144 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103198 103166 103173 103139 103161 103167 103168 103172 103177 123021 100216 14804 14603 100208 100209 102138 15819 102145 102147 103160 103079 123004 15829 102221 103123 103124 103131 15135 15136 100306 100309 103019 14123 103022 103145 103148 103152 15920 15904 103053 15909 103114 15902 15903 103040 103042 14312 103039 103130 103200 14900 103116 103117 103119 18900 18901 14902 15927 15928 15901 103008 103216 103189 103208 15925 15926 103194 103115 103014 103170 15923 15924 |
| Center Classification Date | 20210419 |
| Recall Initiation Date | 20210304 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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