Sensis Vibe Hemo recallZ-0683-2024 · Siemens Medical Solutions USA, Inc · initiated Nov 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The possibility of the Sensis documentation functionality application to crash.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0683-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 29, 2023
- Posted by the FDA
- Jan 9, 2024
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 331 units
- Product code
- DQK
- FDA submissions
- K223812
- Distribution
- Domestic: CA, CT, & FL.
Product description
Sensis Vibe Hemo
Code information (models, lots, serial numbers)
Model No. 11007641; UDI-DI 04056869010199; Serial No. 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, 18015.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sensis Vibe Hemo 11007641Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE4 recalls1 death22 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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