Recall Z-0683-2024

Reason for recall

The possibility of the Sensis documentation functionality application to crash.

FDA-determined cause: Software design

Action taken

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.