Medical X-ray display system support arm may lower unexpectedly
Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of medical device with mechanical failure hazard (support arm descent) that may result in injury. No illnesses or injuries reported in source; hazard is potential. Classified as High per rubric criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling LUMINOS Lotus Max medical imaging systems (Model 11574100). The systems are ceiling or wall-mounted X-ray display equipment with an adjustable support arm.
The support arm may lower unintentionally while the display is being positioned. This creates a risk of injury to people standing beneath the equipment during positioning operations.
The recall affects 26 units distributed nationwide in the United States. Affected facilities can identify units by the serial numbers listed in the FDA recall notice.
Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for instructions on remediation or replacement.
The recalled product
- Product
- LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 26
Distribution
Distributed nationwide across the United States.
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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