Potential component failure in the Gradient Coil could product smoke and/or fire.
Reason for recall: Potential component failure in the Gradient Coil could product smoke and/or fire. Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta Quantity: 1 unit Lot/code info: Product No. 781105; UDI-DI: N/A; Serial No. 8187.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.