Siemens x-ray display system support arm may lower unexpectedly
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
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: This is a risk-of-harm product (structural mechanical failure in medical equipment) where no injuries have been reported, meeting the score 3 criterion per the rubric: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Luminos Agile Max x-ray imaging system (Model 10762472). The support arm may unintentionally lower during display positioning, creating a risk of injury to persons positioned beneath the ceiling or wall-mounted display.
Approximately 333 units have been distributed nationwide across the United States. Specific serial numbers are identified in the FDA recall notice.
The recalled product
- Product
- Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Affected units
- 333
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 (1)
- UDI: (01)04056869009162(21) Serial Numbers
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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