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U.S. Department of Health and Human Services

Class 2 Device Recall Millenium

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 Class 2 Device Recall Milleniumsee related information
Date Initiated by FirmSeptember 12, 2025
Date PostedOctober 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0299-2026
Recall Event ID 97647
Product Classification System, tomography, computed, emission - Product Code KPS
ProductMillenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Code Information all serial numbers in distribution
Recalling Firm/
Manufacturer		 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
9, Andrey Sakharov
Haifa Israel
For Additional Information ContactGE HealthCare Service
800-437-1711
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Package design/selection
ActionGE 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.
Quantity in Commerce292 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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