Patient table footrest may detach from AXIOM Luminos Agile
Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential 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 an FDA Class II medical device recall with potential for patient injury (footrest detachment during use), but no reported injuries or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the AXIOM Luminos Agile patient table due to a potential footrest detachment hazard. The footrest may detach from the patient table during use.
Approximately 271 units of this equipment (Material #10502200) have been distributed worldwide. All serial numbers of the AXIOM Luminos Agile are affected by this recall.
Affected healthcare facilities should contact Siemens Medical Solutions USA, Inc. immediately for guidance on this recall.
The recalled product
- Product
- AXIOM Luminos Agile
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 271
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 (2)
- All serial numbers for AXIOM Luminos Agile
- Material #10502200 (no UDI)
Distribution
Distribution scope not specified by the agency.
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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