Z-1554-2025 Class II Ongoing
FDA device recall Z-1554-2025 was initiated by Philips North America Llc on March 10, 2025 and is designated Class II. Reason for recall: Potential for collimator to fall as a result of incorrect installation. The recall status is ongoing. Affected quantity: 83 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units
Product Description
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Reason for Recall
Potential for collimator to fall as a result of incorrect installation.
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.
Code Information
REF 712214; UDI: (01)00884838064751(21); Serial No. SN170009, SN170010, SN180072, SN180020 200037, SN160061, SN180075, 200089, SN180045, SN160096.