X-Ray System Collimator Fall Risk Due to Incorrect Installation
Philips DXR System X-ray units may have a collimator that could fall if installed incorrectly. Healthcare facilities should verify proper installation of affected units.
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 a risk-of-harm medical device where falling equipment could cause injury, but no illnesses or injuries have yet been reported. FDA Class II classification reflects the safety concern warranting recall.
Plain-English summary
Philips North America LLC is recalling 83 units of the Philips DXR System, DuraDiagnost Rel. 4, a stationary X-ray system used in diagnostic imaging. The recall addresses a potential hazard where the collimator—a component that shapes and directs the X-ray beam—could fall as a result of incorrect installation.
The hazard arises when the collimator is not installed correctly. If the collimator falls, it could pose a risk of injury to patients or healthcare workers near the equipment.
The affected units were distributed nationwide in the United States in Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, and Wisconsin. International distribution includes 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, and Vietnam. Affected serial numbers include SN170009, SN170010, SN180072, SN180020, SN200037, SN160061, SN180075, SN200089, SN180045, and SN160096.
Healthcare facilities should verify that the collimator is installed correctly on their Philips DXR System units. Contact Philips North America LLC if installation verification or corrective action is needed.
The recalled product
- Product
- Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
- Manufacturer
- Philips North America Llc
- Hazard
- equipment-fall
- installation-defect
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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