GE Medical Systems, LLC: Device Recall

Recall Details

Recall Number

Z-0156-2026

Classification

Class II

Product Type

Device

Recalling Firm

GE Medical Systems, LLC

Status

Ongoing

Date Initiated

09/18/2025

Location

Waukesha, WI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

31 units

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.

Product Description

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

Distribution Pattern

US Nationwide. Global Distribution.

Other Recalls by GE Medical Systems, LLC

• Class II: Risk 10/24/2025
  Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
• Class II: Risk 09/18/2025
  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.
• Class II: Risk 09/18/2025
  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.
• Class II: Risk 08/22/2025
  If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
• Class II: Risk 07/02/2025
  GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.

View all recalls by GE Medical Systems, LLC →