GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

FDA device recall Z-0935-2026 · posted 2025-12-16 · Open, Classified

Recall details

Recalling firm

GE Healthcare GmbH

Reason for recall

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

Action taken

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/3/2025 via letter distributed using a traceable means. The notice explained the issue, safety issue/risk, and requested the following: Actions to be taken by Customer/User: "Pending correction by GE HealthCare, you can continue to use your device by following the instructions below: When creating or opening an exam on ViewPoint 6 version 6.15.3 or ViewPoint 6 version 6.15.4, if using the patient history tab, do not rely on the information. Always confirm that essential patient history data is correct (e.g., Allergies, Medications, Past Medical History, Past Surgical History, Obstetric and Gynecologic History, Infections). Sources of confirmation include the patient, the Electronic Medical Record (EMR), or prior exams, etc. If you have downloaded ViewPoint 6 version 6.15.3 or ViewPoint 6 version 6.15.4 but have not installed it, please do not proceed with the installation of these versions. In order to determine the version of ViewPoint 6 you are using, follow the instructions below: 1. Open the Help menu. 2. Select About. 3. The version is available in the top right part of the window. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete the Acknowledgement Form in GE HealthCare ViewPoint e-distribution portal. GE HealthCare will correct this issue with a software patch and will notify you by e-mail when the patch is available. You can install the patch yourself or contact GE HealthCare Service or your local authorized Service Representative to install the patch for you. GE HealthCare will correct all affected products at no cost to you." For questions or concerns regarding this notification, please contact your local GE HealthCare Service at 1-877-644-3114 or local Representative. Alternatively, you can contact GE HealthCare Servic

Root cause

Device Design

Status

Open, Classified

Product code

LLZ

Quantity affected

1221 units

Distribution

Worldwide

Date initiated

2025-11-03

Date posted

2025-12-16

Location

Munich, Germany

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