FDA-Device2025-04-23Class II

Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

Philips North America Llc
Hazard

Potential for collimator to fall as a result of incorrect installation.

Sold states
Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, Slovenia, South Africa, Spain, Thailand, United Kingdom, Vietnam.
Affected count
83 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1554-2025

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