Medical X-ray equipment patient table footrests recalled due to detachment risk
Siemens recalls four fluoroscopy and radiographic imaging equipment models worldwide because patient table footrests may detach during clinical use, potentially causing patient injury.
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 a risk-of-harm medical device where a structural defect (footrest detachment) could cause patient injury, but no incidents or injuries have been reported to the FDA. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled four models of medical imaging equipment: the AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200, and AXIOM Luminos dRF. All serial numbers of these devices are affected.
The footrest on the patient table for these devices may detach during clinical use, creating a potential risk to patients.
A total of 654 units have been distributed worldwide. Healthcare facilities and physicians using these devices should inspect them and contact Siemens Medical Solutions for guidance on remediation or replacement. Individuals who believe they have experienced an adverse event with these devices are urged to report to the FDA MedWatch program.
The recalled product
- Product
- AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- footrest-detachment
- fall-risk
- structural-defect
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 (6)
- All serial numbers 1) AXIOM Luminos TF
- Material #10093902 (no UDI) 2) AXIOM Iconos R100
- Material #05895151 (no UDI) 3) AXIOM Iconos R200 C69
- Material #10093961 (no UDI) 4) AXIOM Iconos R200 C20
- Material #10093962 (no UDI) 5) AXIOM Luminos dRF
- Material #10094200 (no UDI)
Distribution
Distribution scope not specified by the agency.
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