Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk
Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (falling collimator on an X-ray system that could injure patients or staff). No illnesses or injuries have been reported in the source text, but the hazard is not purely theoretical—it is a mechanical failure mode with direct injury potential. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 83 units of the Philips DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to a potential for the collimator to fall as a result of incorrect installation. The affected units are identified by serial numbers SN170009, SN170010, SN180072, SN180020, 200037, SN160061, SN180075, 200089, SN180045, and SN160096.
The devices have been distributed nationwide across Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, and Wisconsin, as well as internationally to Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, the Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, the Russian Federation, Slovenia, South Africa, Spain, Thailand, the United Kingdom, and Vietnam.
If you own or operate one of these units, verify the installation of the collimator to ensure it is properly secured. Contact Philips North America LLC for guidance on inspection and corrective action. For more information, refer to the FDA recall notice Z-1554-2025.
The recalled product
- Product
- Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — X-Ray System
- Hazard
- collimator-fall
- installation-defect
- impact-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- REF 712214
- UDI: (01)00884838064751(21)
- Serial No. SN170009
- SN170010
- SN180072
- SN180020 200037
- SN160061
- SN180075
- 200089
- SN180045
- SN160096.
Distribution
Distributed nationwide across the United States.
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