FDA-Device2020-10-07Class II

ProxiDiagnost N90

Philips North America, LLC
Hazard

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

Sold states
United States
Affected count
71
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
ProxiDiagnost N90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3023-2020

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