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Sensis/ Sensis Vibe Hemo systems with VD12A software as… recallZ-1434-2021 · Siemens Medical Solutions USA, Inc · initiated Mar 4, 2021

Class II Terminated All recalls posted in April 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. .

Recall details

Recall number
Z-1434-2021
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 4, 2021
Posted by the FDA
Apr 19, 2021
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
99 units
Product code
DQK
FDA submissions
K150493
Distribution
US Nationwide distribution.

Product 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

Code information (models, lots, serial numbers)

Serial Numbers: As of 8/24/22 (Updated) 10661 11657 14000 14012 14123 14312 14603 14804 14900 14902 15010 15130 15135 15136 15819 15829 15902 15903 15904 15908 15913 15915 15916 15917 15920 15923 15924 15925 15926 15927 15928 18900 18901 100208 100209 100216 100306 100309 102138 102145 102147 102221 102326 103014 103019 103022 103039 103040 103042 103047 103048 103079 103080 103082 103086 103088 103089 103090 103108 103111 103114 103115 103116 103117 103119 103123 103124 103130 103131 103139 103144 103145 103148 103152 103160 103161 103166 103167 103168 103170 103171 103172 103173 103177 103178 103182 103184 103186 103189 103193 103194 103196 103198 103199 103200 103208 103216 123004 123021

Other devices under the same FDA submission

1 device cleared under K150493 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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