SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Reported: December 4, 2024 Initiated: October 28, 2024 #Z-0519-2025
Product Description
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 3 units
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System. Recalled by GE Medical Systems, LLC. Units affected: 3 units.
Why was this product recalled? ▼
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0519-2025.
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