Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image…

Recall date
August 12, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2681-2016
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
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, L…

Why it was recalled

A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).

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