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FDA (Device enforcement)Recalled 2025-03-10class ii

Philips North America Llc: Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Hazard

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

Details from the source

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. Quantity: 83 units Lot/code info: REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

UPC codes

00884838095205

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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