Philips DXR stationary X-ray system recalled due to collimator installation defect
Philips is recalling 83 DXR X-ray systems worldwide due to a potential installation defect that could cause the collimator to fall during operation.
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: FDA Class II medical device with potential for mechanical harm (collimator fall). No reported injuries, illnesses, or hospitalizations. Per the rubric, risk-of-harm products where injury has not been reported are classified as High (Score 3).
Plain-English summary
Philips North America is recalling 83 units of the Philips DXR System, DuraDiagnost 4.1 stationary X-ray system. The recall is due to a potential for the collimator to fall as a result of incorrect installation. Affected units have serial numbers 220025, 210023, 220171, 230103, and 230152 (UDI: (01)00884838095205(21)).
The recalled systems were distributed nationwide across ten U.S. states (Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, and Wisconsin) and internationally to 25 countries including 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.
Healthcare facilities using these systems should verify that the collimator has been installed correctly. Any concerns about these devices should be reported to Philips North America.
The recalled product
- Product
- Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
- Manufacturer
- Philips North America Llc
- Hazard
- collimator-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 (7)
- REF 712203
- UDI: (01)00884838095205(21)
- Serial No. 220025
- 210023
- 220171
- 230103
- 230152.
Distribution
Distributed nationwide across the United States.
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