FDA recall Z-0519-2025

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-10-28

Report date

2024-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0519-2025