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Philips Medical Systems, Inc. recalls Ingenia 1.5T R5, magnetic resonance imaging system.
Recalled July 2, 2014 · FDA recall Z-1863-2014 · Philips Medical Systems
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. · FDA Class II
Units
33
Sold at
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.
Description
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.
Product
Ingenia 1.5T R5, magnetic resonance imaging system.
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →