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Philips Medical Systems (Cleveland) Inc recalls Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intend
Recalled May 20, 2015 · FDA recall Z-1607-2015 · Philips Medical Systems (Cleveland)
Hazard
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned. · FDA Class II
Units
975 units
Sold at
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.
Description
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Product
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →