Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Velara Generator with an old Firmware version used with the Philips Integris BH5000

Recall date
December 9, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1062-2017
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
US: AL, CA, DC, IL,GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA OUS: Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland Switzerland, Turkey, United Kingdom

Why it was recalled

System may lock up.

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

What was recalled

Velara Generator with an old Firmware version used with the Philips Integris BH5000

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