FDA-Device2014-07-02Class II
Ingenia 1.5T, magnetic resonance imaging system.
Philips Medical Systems, Inc.
Hazard
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.
Affected count
24
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Ingenia 1.5T, magnetic resonance imaging system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1865-2014Don't want to check this manually?
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