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U.S. Department of Health and Human Services

Class 2 Device Recall Sensis Vibe Hemo

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  Class 2 Device Recall Sensis Vibe Hemo see related information
Date Initiated by Firm November 29, 2023
Date Posted January 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-0683-2024
Recall Event ID 93637
510(K)Number K223812  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Sensis Vibe Hemo
Code Information Model No. 11007641; UDI-DI 04056869010199; Serial No. 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, 18015.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 The possibility of the Sensis documentation functionality application to crash.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 11/29/23 by mail to consignees to notify them of this recall event. In the case this failure mode occurs during use, consignees are asked to continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. It is instructed that consignees can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. The recalling firm will deploy a software update via Update Instruction AX010/23/S to correct the error. A member of the service organization will contact consignees to schedule the update. Consignees can contact the service organization at 1-800-888-7436 to schedule an earlier appointment. The recall notice is to be disseminated to all users of affected products within consignee organizations and others who may need to be informed. Consignees are to return the provided response form by email to recallsandrefusals.team@siemens-healthineers.com within 14 days of receipt.
Quantity in Commerce 331 units
Distribution Domestic: CA, CT, & FL.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions USA Inc.
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