Philips North America Llc: Philips DXR System, DuraDiagnost Rel. 4. 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 712214; UDI: (01)00884838064751(21); Serial No. SN170009, SN170010, SN180072, SN180020 200037, SN160061, SN180075, 200089, SN180045, SN160096.

UPC codes

00884838064751

Source

Official record: FDA (Device enforcement) ↗

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