FDA-Device2020-03-25Class II
Poly G Integris H5000, System code 72246
Philips North America, LLC
Hazard
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Sold states
Nationwide domestic distribution. Foreign distribution worldwide.
Affected count
1
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Poly G Integris H5000, System code 72246
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2020Don't want to check this manually?
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