FDA-Device2017-02-01Class II

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

Philips Electronics North America Corporation
Hazard

System may lock up.

Sold states
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
Affected count
59 devices (this number represents all products listed in recall)
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Velara Generator with an old Firmware version used with the Philips Integris BH5000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1062-2017

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