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U.S. Department of Health and Human Services

Class 2 Device Recall MAXXUS

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 Class 2 Device Recall MAXXUSsee related information
Date Initiated by FirmDecember 10, 2025
Date PostedJanuary 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1047-2026
Recall Event ID 98133
510(K)NumberK924498 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductMAXXUS, System, Tomography, Computed, Emission
Code Information UDI/DI Not applicable: All serial numbers in distribution
Recalling Firm/
Manufacturer		 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
4, Hayozma St
Tirat Carmel Israel
Manufacturer Reason
for Recall		GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA Determined
Cause 2		Package design/selection
ActionGE Healthcare began notifying their consignees by telephone on 12/10/2025, followed by an URGENT MEDICAL DEVICE CORRECTION UPDATE notice distributed on 01/05/2025 via US mail. The notice explained the issue, safety risk, and requested the consignee stop use of the product. Care should be exercised when deinstalling these systems. To discuss replacement options, your GE HealthCare account representative. Should be contacted.
Quantity in Commerce38 units
DistributionUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
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.
510(K) Database510(K)s with Product Code = KPS
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