FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Recall number
- Z-0155-2026
- Recalling firm
- GE Medical Systems, LLC
- Product
- LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Status
- Open, Classified
- Initiated
- 2025-09-18
- Posted
- 2025-10-15
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- An 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
- 65 units
- Distribution
- US Nationwide. Global Distribution.
- Lot, serial or model codes
- Model 5877534 UDI-DI: 00195278464644, Serial Numbers: LPX441358 LPX441335 LPX440894 LPX440598 LPX440898 LPX441357 LPX441328 LPX441402 LPX441407 LPX441405 LPX441326 LPX441126 LPX441406 LPX441403 LPX441404 LPX441439 LPX441440 LPX441327 LPX441043 LPX441399 LPX441370 LPX441422 LPX441369 LPX441001 LPX441447 LPX440990 LPX441374 LPX441376 LPX441428 LPX441453 LPX441427 LPX440999 LPX441373 LPX441420 LPX441384 LPX441375 LPX441421 LPX441424 LPX441371 LPX441425 LPX441426 LPX441367 LPX441368 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452
- 510(k) numbers
- K214039
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28