Recalls / —

—#204998

Product

Sensis Vibe Hemo

FDA product code

DQK — Computer, Diagnostic, Programmable

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K223812

Affected lot / code info

Model No. 11007641; UDI-DI 04056869010199; Serial No. 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, 18015.

Why it was recalled

The possibility of the Sensis documentation functionality application to crash.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Domestic: CA, CT, & FL.

Timeline

Recall initiated

2023-11-29

Posted by FDA

2024-01-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204998. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.