The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1460-2014·Announced 2014-04-23

Siemens AXIOM Vertix MD Trauma Systems Recalled for U-Arm Drop Risk

Siemens is recalling two AXIOM Vertix MD Trauma systems because defective steel ropes may cause the U-arm to drop unexpectedly, posing a risk of serious injury to patients.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the defect can result in 'serious injury,' which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports or risks.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058. The recall was initiated due to a potential defect in the steel ropes inside the lift column of the system.

In rare cases, these steel ropes can be defective without triggering the safety lock. This failure can result in the U-arm dropping down unexpectedly during vertical movement, which poses a potential hazard to patients and could cause serious injury.

The affected units were distributed in the United States, including Missouri and Ohio. Siemens is the recalling firm for this Class II recall.

The recalled product

Product
AXIOM Vertix MD Trauma systems radiographic X-ray
Affected units
2

Distribution

Distributed in 2 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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