FDA-Device2016-09-07Class II
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Philips Electronics North America Corporation
Hazard
A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
Sold states
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, TX, VT, WA, WI, WV, and WY; and, the countries of Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.
Affected count
388
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2681-2016Don't want to check this manually?
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