FDA-Device2015-05-20Class II
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Philips Medical Systems (Cleveland) Inc
Hazard
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Sold states
Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Egypt, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Lebanon, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, South Korea, Spain,Thailand and United Kingdom.
Affected count
975 units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1607-2015Don't want to check this manually?
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