Luminos dRF Max X-ray Display Support Arm May Unintentionally Lower
Siemens recalled 24 units of the Luminos dRF Max X-ray display system because the support arm may unintentionally lower, potentially injuring personnel positioned beneath the equipment.
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 recall with a mechanical failure (support arm lowering) that poses a risk of injury to healthcare personnel. No injuries or hospitalizations are reported in the source material, placing this in the High category per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos dRF Max X-ray display system (Model 10762471) due to a mechanical hazard involving the support arm. The FDA classified this as a Class II recall.
The support arm may unintentionally lower during positioning of the display system, which could result in injury to persons positioned beneath the ceiling or wall-mounted display when the arm descends unintentionally.
This recall affects 24 units distributed nationwide in the United States. The affected units can be identified by the following serial numbers: 8320, 8198, 8334, 8474, 8183, 8322, 8613, 8244, 8660, 8436, 8095, 8371, 8378, 7805, 5664, 5615, 8150, 8130, 8300, 8093, 8468, 7791, 8479, and 7136.
Healthcare facilities with affected units should contact Siemens Medical Solutions USA, Inc. to confirm whether their equipment is subject to this recall and to determine appropriate remediation. Until the issue is resolved, personnel should exercise caution when positioning the display system.
The recalled product
- Product
- Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- mechanical-failure
- drop-hazard
- injury-risk
Distribution
Distributed nationwide across the United States.
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