GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint Helix

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 9/12/2025 via letter (USPS first class). The notice explained the issue, potential safety issue, and requested the following: "Actions to be taken by Customer/User: You have previously been formally notified that these Impacted Systems have reached their End of Guaranteed Service life. GE HealthCare does not have the ability to correct these devices. GE HealthCare requests you to immediately STOP USING your Impacted System(s). As these devices are no longer supported and are no longer serviceable, continued use may compromise patient or user safety, negatively impact product performance, or introduce other risks to patients, users, and facilities. This is the final communication from GE HealthCare regarding these devices. Please ensure all potential users in your facility are made aware of this Stop Use safety notification. Take care when deinstalling the system, ensuring the system is balanced and all parts are secure. If you require assistance in removal and disposal of your system, please contact your local GE HealthCare representative. If you would like to discuss your replacement options, please contact your GE HealthCare account representative. Please retain this document for your records. Contact Information: If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." On 10/01/2025, the firm sent a follow-up notice removing Millenium VG from this action as it was erroneously included in the first notice.

• FDA enforcement recordOfficial FDA database entry for Z-0295-2026
• FDA device classification · KPSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.