FDA recall Z-1554-2025

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2025-03-10

Report date

2025-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

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