Medical device recalls Moderate risk

Philips North America, LLC recalls EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Recall date
June 2, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2523-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.

Why it was recalled

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

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

What was recalled

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

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