Achieva 1.5T Initial System

Reason: Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information: Product No. 781178; UDI-DI: N/A; Serial No. 21605, 21695.

Distribution pattern: 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, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.