Date Initiated by Firm | March 04, 2021 |
Date Posted | April 19, 2021 |
Recall Status1 |
Terminated 3 on September 30, 2024 |
Recall Number | Z-1434-2021 |
Recall Event ID |
87515 |
510(K)Number | K150493 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
Product | 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 |
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
|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355
|
For Additional Information Contact | SAME 610-219-4834 |
Manufacturer Reason for Recall | 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 Determined Cause 2 | Software design |
Action | 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.
. |
Quantity in Commerce | 99 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQK
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