GE Medical Systems, LLC: Device Recall

Recall Details

Recall Number

Z-0517-2025

Classification

Class II

Product Type

Device

Recalling Firm

GE Medical Systems, LLC

Status

Ongoing

Date Initiated

10/28/2024

Location

Waukesha, WI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

8 units

Reason for Recall

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Product Description

Discovery MR750w 3.0T, whole body magnetic resonance scanner

Distribution Pattern

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

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 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.

View all recalls by GE Medical Systems, LLC →