The Recall Desk
HighFDA (Devices)·Z-1001-2023·Announced 2023-01-25

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.

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: 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
Category
Medical Device — Medical Imaging Equipment
Hazard
  • footrest-detachment
  • fall-risk

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.

Related recalls

Same category