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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Sensis Vibe Hemo

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  Class 2 Device Recall Siemens Sensis Vibe Hemo see related information
Date Initiated by Firm July 24, 2020
Date Posted August 28, 2020
Recall Status1 Terminated 3 on November 02, 2021
Recall Number Z-2921-2020
Recall Event ID 86179
510(K)Number K150493  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Code Information Serial Numbers: 100413 100414 100417 101016 101017 101019 101020 101022 101029 101031 101036 100263 100416 102008 101083 102138 102019 102021 102025 102029 102145 102147 100346 100349 102199 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 102272 102068 102069 102078 102080 102093 102221 100163 100165 100306 100309 101056 101099 101100 101101 101060 101068 101069 101070 101071 101072 100064 100422 100279 100408 100410 100411 100412 101043 102162 102285 102286 102183 100231 102060 102062 102049 102051 102057 102030 102031 101008 101093 101094 100175 100176 102226 101097 102269 102273 102276 102278 102279 102283 102193 102155 102157 102174 102182 102181 102214 102216 102219 102222 102237 102242 100391 101089 101095 102274 101018 102143 102091  9/01/20 Expanded S/N: 11007641 11007641 11007641  ***9/28/20 Expanded S/N*** 103053 103040 103042 103008  
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
The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost
FDA Determined
Cause 2
Process design
Action Siemens issued Customer Safety Advisory Notice distributed dated July 24 2020 to customers via AX048/20/S. Letter states reason for recall, health risk and action to take: If the connector linking the EtCO2 module to the HemoBox should become damaged or break, the operator shall not attempt to fix the connector or re-connect the cable to the HemoBox. Only Siemens Customer Service representative or a service provider authorized by Siemens Healthineers may resolve the issue. Siemens strongly recommends that you do not attempt to fix the connector or re-connect the cable to the HemoBox until the problem has been corrected by a service engineer. Siemens is currently developing a solution to eliminate the root cause of this problem. Our service organization will contact you when a solution has been initiated to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented.
Quantity in Commerce 110 units US
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.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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