Z-0683-2024Class II

Sensis Vibe Hemo

Name: Z-0683-2024 Sensis Vibe Hemo
Creator: Siemens Medical Solutions USA, Inc
Published: 2023-11-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2023-11-29 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sensis Vibe Hemo on 2023-11-29. FDA classified it as Class II and gives the reason as "The possibility of the Sensis documentation functionality application to crash". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0683-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-29
Posted: 2024-01-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sensis Vibe Hemo
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The possibility of the Sensis documentation functionality application to crash.
Root cause tag: software
FDA root cause: 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 [email protected] within 14 days of receipt.
Quantity in commerce: 331 units
Distribution: Domestic: CA, CT, & FL.
Product codes and lots: Model No. 11007641; UDI-DI 04056869010199; Serial No. 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, 18015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0683-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0683-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09

Product code DQK

K223812Class IISensis Vibe (VD15)Siemens Medical Solutions USA, Inc. / cleared 2023-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)