Philips DXR System X-Ray Equipment Collimator Fall Hazard Recall
Philips is recalling certain DXR System DuraDiagnost 4.1 stationary X-ray systems due to a potential for the collimator to fall if installed incorrectly.
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 recall involving a risk-of-harm medical device (falling collimator during use or maintenance could cause injury), where no reported injuries or illnesses are stated in the source. Per the rubric, high-risk scenarios with no reported adverse events score at most 3 (High).
Plain-English summary
Philips North America LLC is recalling the Philips DXR System, DuraDiagnost 4.1 Stationary X-Ray System. The equipment has a potential for the collimator to fall as a result of incorrect installation.
The recall affects 83 units distributed nationwide in Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas, and Wisconsin, as well as internationally in 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 220025, 210023, 220171, 230103, and 230152.
Facilities with affected systems should verify correct installation of the collimator. Patients and healthcare providers should contact Philips for further instructions.
The recalled product
- Product
- Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — X-Ray Equipment
- Hazard
- fall-hazard
- incorrect-installation
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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