Philips North America Llc: Device Recall
Recall #Z-1553-2025 · 03/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1553-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America Llc
- Status
- Ongoing
- Date Initiated
- 03/10/2025
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units
Reason for Recall
Potential for collimator to fall as a result of incorrect installation.
Product Description
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
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.
Other Recalls by Philips North America Llc
- Class II: Risk 12/12/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.