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Recall Observatory FDA recall evidence

Device product

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Z-1553-2025

March 10, 2025

Class II

Product summary

Firm
Philips North America Llc
Event
Event 96435
Status
Ongoing
Classification
Class II
Quantity
83 units
Official record key
device-enforcement:Z-1553-2025

Official wording

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

Code information: REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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