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U.S. Department of Health and Human Services

Class 2 Device Recall LOGIQ P10 series with software version R4.5.7

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 Class 2 Device Recall LOGIQ P10 series with software version R4.5.7see related information
Date Initiated by FirmSeptember 18, 2025
Date PostedOctober 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0156-2026
Recall Event ID 97726
510(K)NumberK214039 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductLOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Code Information Model Number 5877535 UDI-DI: 00195278464668, Serial Numbers: LPZ490338 LPZ490347 LPZ490339 LPZ490147 LPZ490292 LPZ490019 LPZ490252 LPZ490348 LPZ490303 LPZ490304 LPZ490305 LPZ490306 LPZ490340 LPZ490350 LPZ490341 LPZ440658 LPZ440673 LPZ440674 LPZ490337 LPZ440641 LPZ440192 LPZ440258 LPZ440694 LPZ440695 LPZ440692 LPZ440632 LPZ440185 LPZ440107 LPZ440168 LPZ440046 LPZ440549
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer Reason
for Recall		The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
FDA Determined
Cause 2		Software design
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/18/25 was sent to customers. Actions to be taken by Customer/User For LOGIQ P9 and LOGIQ P10 series ultrasound systems with system software version R4.5.7, discontinue using the UGAP feature (please see Appendix for product identification). You may continue using other imaging features. After the correction has been implemented, please destroy the installation media for software R4.5.7 at your site. 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 and return the attached acknowledgement form to recall.74084@gehealthcare.com. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. 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.
Quantity in Commerce31 units
DistributionUS Nationwide. Global Distribution.
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 = IYN
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