Siemens Luminos dRF Max Recalled for Collision Control Override Risk
Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.
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: The recall involves a risk of physical collision with persons or obstacles, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 46 units of the Luminos dRF Max, Model No. 10762471. This medical device is intended to visualize anatomical structures by converting X-ray patterns into visible images for various examinations, including gastrointestinal, cranial, skeletal, thoracic, and urogenital tract studies.
The recall was initiated because Siemens became aware of an issue where the incorrect use of a bypass key can override the device's built-in collision control. This malfunction creates a risk of collision with obstacles or persons when the operator uses the override function.
The affected units were distributed nationwide in the United States. The specific serial numbers for the recalled units are listed in the agency's official record. Users of this equipment should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this safety issue.
The recalled product
- Product
- Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 46
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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