FDA-Device2025-04-23Class II
Philips DXR System, DuraDiagnost 4.1. 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 4.1. Stationary X-Ray System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1553-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief