Device product
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Z-1554-2025
Product summary
- Event
- Event 96435
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 83 units
- Official record key
device-enforcement:Z-1554-2025
Official wording
Reason: Potential for collimator to fall as a result of incorrect installation.
Code information: REF 712214; UDI: (01)00884838064751(21); Serial No. SN170009, SN170010, SN180072, SN180020 200037, SN160061, SN180075, 200089, SN180045, SN160096.
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
Potential for collimator to fall as a result of incorrect installation.