Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk
Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.
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 is classified as FDA Class II and involves 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 Siemens AXIOM Luminos dRF Max systems due to two identified malfunctions that pose a potential risk to patients. The affected systems are intended for use as universal diagnostic imaging systems for radiographic and fluoroscopic studies.
The malfunctions cause lost images due to an automatic Radiology Information System (RIS) worklist update, which results in examinations being repeated. Additionally, image labels may be displayed incorrectly after images are acquired. These issues are associated with specific serial numbers.
The recall covers systems distributed nationwide in the US, including Utah, Missouri, Colorado, Massachusetts, Minnesota, Mississippi, Ohio, South Carolina, Michigan, and New York. Affected units include material number 10762471 with serial number 5037. Healthcare facilities should contact Siemens for further instructions on how to address these malfunctions.
The recalled product
- Product
- Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and p
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 4 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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