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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm January 27, 2021
Create Date March 04, 2021
Recall Status1 Terminated 3 on October 25, 2021
Recall Number Z-1173-2021
Recall Event ID 87273
510(K)Number K150493  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Model Numbers:
Sensis Vibe Hemo 11007641
Sensis Vibe Combo 11007642
Sensis 10764561
Postprocessing Workstation 6648161
SIS Server 6648153
Code Information Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers:  10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004 
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		 System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
FDA Determined
Cause 2		 Software design
Action Siemens issued Urgent Medical Device Correction via Customer Safety Advisory Notice AX010/21/S dated 1/27/21distributed to all affected customers. Additionally, a solution to eliminate the root cause of this problem is being distributed via Update Instruction AX009/21/S to all affected customers. Letter states reason for recall, health risk and action to take: The freeze is a total lock-up of the system and requires a power cycle of the PC to recover. Please make sure that an alternative system can be used to continue treatment in such cases.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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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 37 US
Distribution US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.
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.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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