FDA Enforcement
Class II
Ongoing
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Recall: Z-1554-2025
·
Reported April 23, 2025
Enforcement
- Recall Number
- Z-1554-2025
- Event ID
- 96435
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 23, 2025
- Initiation Date
- March 10, 2025
- Classification Date
- April 11, 2025
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
Description
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Reason
Potential for collimator to fall as a result of incorrect installation.
Code Info
REF 712214; UDI: (01)00884838064751(21); Serial No. SN170009, SN170010, SN180072, SN180020 200037, SN160061, SN180075, 200089, SN180045, SN160096.
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